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Showing 20 of 26908 trials
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
NCT06318897
Recruiting
Conditions Stage 1 cT1b-T1cN0M0, Triple Negative Br...
Phase PHASE2
Enrollment 28
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Carboplatin — Given by IV
  • Drug: Paclitaxel — Given by IV
  • Drug: Pembrolizumab — Given by IV
  • Drug: Doxorubicin — Given by IV
  • Drug: Cyclophosphamide — Given by IV

Primary Outcomes

  • Safety and adverse events (AEs) (Through study completion; an average of 1 year.)
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-05-29
Completion: 2027-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 28 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Principal Investigators:
  • Oluchi Oke, MD (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
Study Contact:
Oluchi Oke, MD
(832) 729-8362
oukaegbu@mdanderson.org
Interventions
  • Drug: Carboplatin — Given by IV
  • Drug: Paclitaxel — Given by IV
  • Drug: Pembrolizumab — Given by IV
  • Drug: Doxorubicin — Given by IV
  • Drug: Cyclophosphamide — Given by IV
Study Locations (1 sites)
MD Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participants must have histologically confirmed ER negative, PR negative and HER2-negative (TNBC) defined as ER\<10%, PR\<10%, and HER2 negative (per 2018 ASCO CAP guidelines). All pathology will be confirmed at the MD Anderson Houston Campus. Participants with tumors designated as HER2 equivocal (per ASCO CAP guidelines) are eligible if in view of treating physician patient is not considered a candidate for HER2-targeted therapy. Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-9% by immunohistochemistry, are eligible if the treating physician considers the participants not eligible for adjuvant endocrine therapy. 2. AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0. All participants with clinically suspicious nodes must undergo core or fine needle biopsy per standard clinical practice to pathologically assess at least 1 suspicious index node. Participants with suspicious nodes that are biopsy negative will be eligible. 3. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage 1 T1b-T1cN0M0 TNBC will be enrolled in this study. 4. Male participants: A male participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period. 5. Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and/or any active comparator/combination) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment. 6. Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. 7. The participant provides written informed consent for the trial. 8. Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (appendix 3). Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. 10. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days prior to the start of study intervention. 11. Non-English speaking participant can enroll in the study as long as they speak a language for which interpretation can be provided by a licensed interpreter either in person or virtually. 12. Criteria for known HIV positive participants. 1. Participants with HIV are eligible if they have well-controlled HIV with negative viral load on ART and must not have had any AIDS-defining opportunistic infections within the past 12 months from initiation of C1D1 study treatment. 2. HIV screening tests are not required unless: i. Known history of HIV ii. As mandated by local health authority 13. Criteria for known Hepatitis B and C positive participants Hepatitis B and C screening tests are not required unless: * Known history of HBV or HCV infection * As mandated by local health authority 13.1 Hepatitis B positive Participants * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. * Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 13.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. * Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Table 3 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) = ≥1500/µL Platelets = ≥100 000/µL Hemoglobin = ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) = ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN Hepatic Total bilirubin = ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT) = ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) = ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Stage 2, 3 or 4 Triple negative breast cancer 2. Hormone Receptor positive and/or Human Epidermal Growth factor 2 (HER 2) positive breast cancer 3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to dose of study drug (see Appendix 2). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 5. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to allocation of therapy. 6. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted. 7. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 8. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. 9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of
Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
NCT06612203
Active, positions filled
Conditions Advanced Breast Cancer
Phase PHASE1, PHASE2
Enrollment 76
Locations 7 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The WIN-B is an international, multicenter, single-arm, phase Ib/II study to evaluate the safety and activity of the Debio 0123 and Sacituzumab govitecan combination therapy in patients with pre-treated advanced/metastatic TNBC or HR+/HER2- breast cancer. Phase Ib will explore if the addition of increasing doses of Debio 0123 to Sacituzumab govitecan is safe and active in pre-treated advanced/metastatic TNBC and HR+/HER2- breast cancer patients. The Debio 0123's recomendad phase 2 doses (RP2D) obtained during phase Ib will then be administered in combination with Sacituzumab govitecan in phase II of the study.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Debio 0123 and Sacituzumab govitecan — Debio 0123 will be administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first.

Primary Outcomes

  • Phase Ib - Debio 0123's recommended phase II dose (RP2D) when administered in combination with Sacituzumab govitecan in patients with TNBC or HR+/HER2- metastatic breast cancer. (Baseline up to 42 days.)
  • Phase II - Efficacy in terms of objective response rate (ORR) as per RECIST v.1.1 in each cohort. (Approximately 9 months from baseline.)
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Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2025-01-17
Completion: 2027-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 76 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: MedSIR
Collaborators: Debiopharm International SA, Gilead Sciences
Principal Investigators:
  • Tim Robinson, BMBS, PhD (PRINCIPAL_INVESTIGATOR) - University of Bristol, Bristol, England (UK)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Debio 0123 and Sacituzumab govitecan — Debio 0123 will be administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first.
Study Locations (7 sites)
Hospital Universitari Dexeus, Barcelona, Spain
Hospital Universitario Clínico San Cecilio de Granada, Granada, Spain
Hospital Beata María Ana, Madrid, Spain
Hospital Universitario Virgen de la Victoria, Málaga, Spain
Hospital Arnau de Vilanova de Valencia, Valencia, Spain
Beatson West of Scotland Cancer Center, Glasgow, United Kingdom
Barts Health NHS Trust, London, United Kingdom
Eligibility Criteria
Inclusion Criteria: 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age at the time of signing ICF. 3. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent. 4. Histologically confirmed TNBC or HR+/HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Note: Patients must have known HR and HER2 status locally determined on the most recent analyzed biopsy or FFPE tumor block prior to study entry. 5. All patients must have been previously treated with taxanes regardless of disease stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given patient. 6. Refractory to at least one, and no more than two, prior standard of care chemotherapy regimens for unresectable locally advanced or metastatic breast cancer. Earlier adjuvant or neoadjuvant therapy for more limited disease will be considered as one of the required prior regimens if the development of unresectable locally advanced or metastatic disease occurred within a 12-month period after completion of chemotherapy. 7. HR+/HER2- breast cancer patients must be refractory to at least 1 prior anti-cancer hormonal treatment for advanced disease and must have resistance to CDK4/6 inhibitor defined as: * Disease progression while on, or within 12 months after the end of this treatment in the (neo)adjuvant setting. * Disease progression to this treatment during advanced disease. 8. For phase Ib: evaluable disease according to RECIST v.1.1; for phase II: measurable disease according to RECIST v.1.1. 9. Patients with bone-only metastatic disease will be allowed to participate only if they have at least one measurable soft-tissue component ≥10 mm. 10. Patients with brain metastasis must have an MRI scan of the brain performed and have had stable CNS disease for at least 4 weeks before entry into the trial. Note: low dose corticosteroids for the treatment of brain metastases are permitted provided the dose is stable for 4 weeks. 11. Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or fresh tumor biopsy at baseline and after detection of disease progression. 12. Able to provide liquid biopsy at the established time points. 13. ECOG performance status of 0-1. 14. Patient must have adequate bone marrow, liver, and renal function. 15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). 16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same period. 17. Male patients who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last administration of the study drug. Male patients must not donate or bank sperm during the same time period. 18. Patient must be accessible for treatment and follow-up visits. Exclusion Criteria: 1. Current participation in another therapeutic clinical trial, except other translational studies. 2. Investigational anti-cancer therapy, chemotherapy or radiotherapy with curative intent within 21 days prior to first dose of study treatment. Note: Palliative radiation (e.g., for pain relief) is allowed up to 1 week prior to study treatment start. 3. Treatment with monoclonal antibodies/biologics within 28 days prior to first dose of study treatment. 4. Has previously been treated with a TROP2-directed antibody-drug conjugate (ADC) or WEE-1 inhibitor in any setting. 5. Has previously been treated with topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase 1 inhibitor in any setting. Note: for phase Ib, prior treatment with topoisomerase 1 inhibitors or ADC-containing a topoisomerase 1 inhibitor in any setting must be specifically evaluated on a case-by-case basis by the Medical Monitor. 6. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, and/or peritoneal\] and pulmonary lymphangitis). 7. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Note: Patients with ≤ 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks. 8. History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 9. Has a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required. 10. Active autoimmune disease that has required systemic treatment in past 2 years or is receiving systemic steroid therapy (e.g., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, or any diagnosis of immunodeficiency. 11. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (Debio 0123 and Sacituzumab govitecan) or their incorporated substances. 12. Major surgical procedure or significant traumatic injury within 14 days before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment. 13. Clinically relevant cardiovascular/cerebrovascular disease and/or cardiac dysfunction or conduction abnormalities. 14. Concomitant use of a drug with a known risk of TdP/QTc prolongation or of any drug(s) described in the prohibited medications section of the protocol. If such a drug has been used by the participant, a wash-out period of at least 5 half-lives of the drug must occur before first administration of study treatment. 15. Concomitant use of a drug or herbal product that is an inhibitor or inducer of CYP enzymes, or of any drug(s) (such as proton pump inhibitors, H2 receptor antagonists, etc.) described in the prohibited medications section of the protocol. If such a drug has been used by the participant, a wash-out period of at least 5 half-lives of the drug must occur before first administration of study treatment. 16. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol. 17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study. 18. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative
Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
NCT02755896
Active, positions filled
Conditions Malignant Neoplasm of Breast Stage I
Phase PHASE2
Enrollment 350
Locations 4 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Radiation: Arm 1 600 cGY x 5 fractions — Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days
  • Radiation: Arm 2 800 cGY x 3 fractions — Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day

Primary Outcomes

  • Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared. (60 months)
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-10-14
Completion: 2027-12
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: false
Enrollment: 350 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Weill Medical College of Cornell University
Principal Investigators:
  • Silvia C Formenti, M.D. (PRINCIPAL_INVESTIGATOR) - Weill Medical College of Cornell University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Radiation: Arm 1 600 cGY x 5 fractions — Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days
  • Radiation: Arm 2 800 cGY x 3 fractions — Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day
Study Locations (4 sites)
University of Southern California, Los Angeles, California 90033 United States
Weill Cornell Medical College, New York, New York 10065 United States
Brooklyn Methodist Hospital - NewYork Presbyterian, New York, New York 11215 United States
New York Presbyterian Hospital - Queens, New York, New York 11355 United States
Eligibility Criteria
Inclusion Criteria: 1. Post-menopausal women with status post segmental mastectomy defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with Follicle Stimulating Hormone (FSH) confirmation of post-menopausal status. 2. Stage 1 (pT1) breast cancer, excised with negative margins. 3. clinically N0 or No Regional Lymph node (pN0) or sentinel node negative Exclusion Criteria: 1. Previous radiation therapy to the ipsilateral breast. 2. Presence of a proportion of Ductal Carcinoma in-situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC).
T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
NCT07152782
Not yet recruiting
Conditions Breast Cancer With Brain Metastasis, HER...
Phase PHASE2
Enrollment 202
Locations 0 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Neratinib — Neratinib, as an irreversible pan-HER tyrosine kinase inhibitor (TKI), holds a unique position in the treatment of HER2-positive breast cancer. From a molecular perspective, Neratinib irreversibly binds to the intracellular kinase domains of HER1 (EGFR), HER2, and HER4 through covalent bonds, comprehensively blocking signal transduction of the HER family. This mechanism of action is markedly different from reversible TKIs such as lapatinib. Neratinib's irreversible binding characteristic allows for a more sustained inhibition of target activity, maintaining anti-tumor effects even after drug plasma concentrations have decreased. This feature is particularly important for HER2-positive breast cancer, which requires continuous suppression of proliferative signals.
  • Drug: Trastuzumab Deruxtecan — Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) composed of an anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a topoisomerase I inhibitor (an exatecan derivative). It targets and binds to HER2-positive tumor cells, internalizes, and releases cytotoxic drugs to induce DNA damage and apoptosis. It also has a "bystander effect" that can kill neighboring tumor cells with low HER2 expression, enhancing anti-tumor activity. T-DXd has shown significant efficacy in HER2-positive advanced breast cancer, with key clinical trials (such as DESTINY-Breast03) confirming that its progression-free survival (PFS) and overall survival (OS) are superior to traditional second-line treatments, with a median PFS reaching 28.8 months. Additionally, for HER2-low-expressing (IHC 1+ or 2+/ISH-) metastatic breast cancer (in the DESTINY-Breast04 study), T-DXd can extend PFS and OS, becoming the first targeted therapy to alter the survival outcomes of such patients

Primary Outcomes

  • Progression Free Survival(PFS) (24 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2025-11
Completion: 2029-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 202 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Contact Information
Study Contact:
Zhimin Shao, Professor
08664175590 Ext. 88807
zhimingshao@yahoo.com
Guantian Lang, Doctor
08664175590 Ext. 65277
langguantian@126.com
Interventions
  • Drug: Neratinib — Neratinib, as an irreversible pan-HER tyrosine kinase inhibitor (TKI), holds a unique position in the treatment of HER2-positive breast cancer. From a molecular perspective, Neratinib irreversibly binds to the intracellular kinase domains of HER1 (EGFR), HER2, and HER4 through covalent bonds, comprehensively blocking signal transduction of the HER family. This mechanism of action is markedly different from reversible TKIs such as lapatinib. Neratinib's irreversible binding characteristic allows for a more sustained inhibition of target activity, maintaining anti-tumor effects even after drug plasma concentrations have decreased. This feature is particularly important for HER2-positive breast cancer, which requires continuous suppression of proliferative signals.
  • Drug: Trastuzumab Deruxtecan — Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) composed of an anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a topoisomerase I inhibitor (an exatecan derivative). It targets and binds to HER2-positive tumor cells, internalizes, and releases cytotoxic drugs to induce DNA damage and apoptosis. It also has a "bystander effect" that can kill neighboring tumor cells with low HER2 expression, enhancing anti-tumor activity. T-DXd has shown significant efficacy in HER2-positive advanced breast cancer, with key clinical trials (such as DESTINY-Breast03) confirming that its progression-free survival (PFS) and overall survival (OS) are superior to traditional second-line treatments, with a median PFS reaching 28.8 months. Additionally, for HER2-low-expressing (IHC 1+ or 2+/ISH-) metastatic breast cancer (in the DESTINY-Breast04 study), T-DXd can extend PFS and OS, becoming the first targeted therapy to alter the survival outcomes of such patients
Eligibility Criteria
Inclusion Criteria: \- Participants must meet all of the following inclusion criteria in order to be enrolled in this study: 1. Female, aged 18-70 years old. 2. ECOG score ranges from 0 to 1. 3. Expected survival period is greater than 12 weeks. 4. Histologically confirmed invasive HER2 positive breast cancer (HER2 IHC+++or FISH/CISH positive, all samples need to be verified by the pathology department of the research center). 5. Tumor staging: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the researcher that radical surgical resection cannot be performed. 6. The subject has at least one lesion (measurable and/or unmeasurable) that has not received radiation therapy in the past. 7. MRI or CT shows brain metastasis and meets one of the following conditions: i) Untreated brain parenchymal metastases detected through imaging screening; Ii) Stable or progressive brain parenchymal metastases that have undergone previous local treatment and meet one of the following conditions: 1. Stable imaging for ≥ 4 weeks; 2. New brain parenchymal metastases detected by MR or CT. 8. Transfer treatment ≤ 2 lines, and did not receive T-DXd or nalatinib. 9. The main organ functions are basically normal, meeting the following conditions: 1. The standard for blood routine examination should meet: HB ≥ 90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L；PLT≥75×109/L； 2. Biochemical tests must meet the following standards: TBIL ≤ 1.5 × ULN (upper limit of normal value); ALT and AST ≤ 3 × ULN; If there is liver metastasis, ALT and AST should be ≤ 5 × ULN; Serum Cr ≤ 1.5 × ULN, endogenous creatinine clearance rate ≥ 30mL/min (Cockcroft Gault formula). 10. Prior to enrollment, the use of mannitol and hormone therapy is allowed, but the medication dosage should be stable for at least one week without the need for an increase. 11. Female participants with fertility agreed to take effective contraceptive measures until 3 months after the last use of medication. 12. The subjects voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up. Exclusion Criteria: \- Subjects with any of the following conditions are not eligible for inclusion in this study: 1. Transfer treatment exceeding 2 lines, or previous use of T-DXd or nalatinib. 2. Meningeal metastasis. 3. Brain metastases that require emergency intervention treatment, or brain metastases that require treatment with more than 3mg/d dexamethasone or equivalent drugs. 4. A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia. 5. Due to ongoing grade ≥ 2 adverse reactions caused by previous treatments (excluding hair loss). 6. Pregnancy period. 7. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 8. Unable to swallow, chronic diarrhea, and intestinal obstruction, there are multiple factors that affect medication intake and absorption. 9. There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid and ascites). 10. Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to the first use of the investigational drug. 11. Long term unhealed wounds or fractures with incomplete healing. 12. Known subjects with active HBV or HCV infection. 13. Active primary immunodeficiency, known to be HIV positive. 14. Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs. 15. A history of non communicable ILD/pneumonia requiring steroids, currently suffering from ILD/pneumonia, or unable to rule out suspected ILD/pneumonia through imaging during screening. 16. Lung standard: 1. Pulmonary specific comorbidities with clinically significant diseases, including but not limited to any potential pulmonary diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc. within 3 months of recruitment). 2. Any autoimmune disease, connective tissue disease, or inflammatory disease (such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.). There are records or suspicions of lung involvement during screening. For participants participating in the study, all detailed information about the disease should be recorded in the CRF. 3. Previous complete lung resection surgery. 17. Individuals with allergies, or those with a known history of allergies to the components of this medication regimen, or subjects who are allergic to other monoclonal antibodies. Researchers believe that substance abuse or medical conditions may interfere with participants' participation in clinical studies or the evaluation of clinical study results.
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
NCT07696754
Not yet recruiting
Conditions Breast Cancer, Breast Neoplasms, Sentine...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study tests whether special imaging goggles can help surgeons find lymph nodes that may be left behind during breast cancer surgery. The goggles show a fluorescent dye (indocyanine green, ICG) that is given during the operation and collects in lymph nodes. In breast cancer surgery, the surgeon removes lymph nodes from the armpit (axilla) to check whether the cancer has spread. Some nodes can be difficult to see and may remain after the surgeon believes the removal is complete. This study looks at whether the goggles can reveal such remaining nodes after the surgeon has declared the axillary surgery finished. Thirty patients having breast cancer surgery with removal of the axillary lymph nodes will take part. After the surgeon states the planned removal is complete, the surgeon will briefly re-examine the area using the goggles and the ICG signal. If additional glowing tissue is seen, the surgeon will decide-using normal surgical judgment-whether it is safe and appropriate to remove it. Any tissue removed this way is examined under the microscope to determine whether it is a lymph node and whether it contains cancer. The study measures how often this additional examination finds cancer-containing nodes that would otherwise have remained, where these nodes are located, whether the finding changes the cancer stage, and how much extra time the examination takes. The study also records any side effects. The results will help determine whether this approach should be studied in a larger trial.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Diagnostic Masking/blinding: None

Interventions / Regimen

  • Device: Augmented-reality ICG fluorescence second-look imaging — A wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.

Primary Outcomes

  • Patient-level rate of clinically significant events (CSE) (From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery))
Interested in this trial?
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-07-10
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ss. Cyril and Methodius University of Skopje
Collaborators: University of Illinois at Urbana-Champaign
Contact Information
Study Contact:
Borislav Kondov, MD
+38972539003
borislav.kondov@medf.ukim.edu.mk
Magdalena Bogdanovska Todorovska, MD
+389709602221
magdalena.todorovska@medf.ukim.edu.mk
Interventions
  • Device: Augmented-reality ICG fluorescence second-look imaging — A wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.
Study Locations (1 sites)
University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM, Skopje, 1000 North Macedonia
Eligibility Criteria
Inclusion Criteria: * Histologically proven breast cancer * Age 18 years or older * Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection * Provides written informed consent Exclusion Criteria: * Pregnancy * Neoadjuvant chemotherapy * Prior breast surgery * Iodine or seafood allergy * Indocyanine green (ICG) allergy * Declines or is unable to provide informed consent
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
NCT03845166
Active, positions filled
Conditions Neoplasm Malignant, Renal Cell Carcinoma...
Phase PHASE1
Enrollment 325
Locations 86 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

Design

Study type: Interventional Phases: Phase1 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: XL092 — oral doses of XL092
  • Drug: Atezolizumab — Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
  • Drug: Avelumab — Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)

Primary Outcomes

  • Dose-Escalation Stage: MTD/recommended dose for XL092 (Up to 24 months)
  • Cohort-Expansion Stage: Objective Response Rate (ORR) (Up to 24 months)
  • Cohort-Expansion Stage (except Cohort H): Progression-Free Survival (PFS) (Up to 24 months)
  • Cohort-Expansion Stage (Cohort H only): Overall Survival (OS) (Up to 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2019-03-20
Completion: 2027-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 325 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Exelixis
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: XL092 — oral doses of XL092
  • Drug: Atezolizumab — Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
  • Drug: Avelumab — Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)
Study Locations (86 sites)
Exelixis Clinical Site #6, Duarte, California 91010 United States
Exelixis Clinical Site #49, La Jolla, California 92093 United States
Exelixis Clinical Site #7, Los Angeles, California 90025 United States
Exelixis Clinical Site #84, Los Angeles, California 90095 United States
Exelixis Clinical Site #66, San Francisco, California 94158 United States
Exelixis Clinical Site #71, Stanford, California 94305 United States
Exelixis Clinical Site #15, Lake Mary, Florida 32746 United States
Exelixis Clinical Site #24, Miami, Florida 33136 United States
Exelixis Clinical Site #11, Atlanta, Georgia 30322 United States
Exelixis Clinical Site #80, Atlanta, Georgia 30342 United States
Eligibility Criteria
Inclusion Criteria: * Cytologically or histologically confirmed solid tumor that is inoperable locally advanced, metastatic, or recurrent. * Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. * Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. * Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. * Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. * Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology. * Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC: * Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab) * Anti-EGFR monoclonal antibody (cetuximab or panitumumab) * BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations * Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1. * Tumor tissue material: * Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Adequate organ and marrow function. * Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception. * Female subjects of childbearing potential must not be pregnant at screening. Exclusion Criteria: * Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, and H only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only). * Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment. * Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment. * Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. * Uncontrolled, significant intercurrent or recent illness. * Concomitant use of certain medications. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 450 ms for males and \> 470 ms for females. Single ECGs are no longer permitted. * Pregnant or lactating females. * Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY: * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. * Administration of a live, attenuated vaccine within 30 days before first dose of study treatment. Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY: * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. * Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
Evaluation of Improved Onboard Patient Imaging
NCT06187103
Active, positions filled
Conditions Head and Neck Cancer, Breast Cancer, Upp...
Phase Not Applicable
Enrollment 40
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Device: HyperSight Imaging — Patients receive standard of care radiation treatment on a Varian TrueBeam system equipped with HyperSight CBCT imaging. Images acquired for daily patient positioning from two different treatment fractions - typically one near the beginning of the treatment course and one at about the halfway point - will be analyzed for the study.

Primary Outcomes

  • Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning. (1 year)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2024-07-10
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Varian, a Siemens Healthineers Company
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: HyperSight Imaging — Patients receive standard of care radiation treatment on a Varian TrueBeam system equipped with HyperSight CBCT imaging. Images acquired for daily patient positioning from two different treatment fractions - typically one near the beginning of the treatment course and one at about the halfway point - will be analyzed for the study.
Study Locations (1 sites)
University of Maryland Medical Center, Baltimore, Maryland 21201-1544 United States
Eligibility Criteria
Inclusion Criteria: 1. Patient is willing and able to provide written consent. 2. Patient is at least 18 years of age at the time of consent. 3. Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis. 4. Patient has ECOG performance status 0-2. 5. Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology. Exclusion Criteria: 1. Patient is pregnant or attempting pregnancy. 2. Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni). 3. Patient receives palliative radiation for 5 or fewer fractions. 4. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response"). This includes prisoners.
Instagram and Podcast Intervention for Breast Cancer Awareness and Screening
NCT07673588
Recruiting
Conditions Breast Cancer, Breast Cancer Screening
Phase NA
Enrollment 180
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Breast cancer is the most common cancer among women worldwide. This randomized controlled trial aims to evaluate the effect of an Instagram- and podcast-based intervention on women's breast cancer awareness, health beliefs, and breast cancer screening behaviors among women aged 20-39 years.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Screening Masking/blinding: Double

Interventions / Regimen

  • Other: Instagram-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy" Instagram account and receive an 8-week Instagram-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE), such as "Do not forget to perform your monthly BSE" and "Remember to perform BSE this week," will be shared on Tuesdays, Thursdays, and Sundays. Stories will also be saved as highlights. No content will be shared on Fridays, and all posts and stories will be published at the same time each day.
  • Other: Instagram-Podcast-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy Plus" Instagram account and receive an 8-week Instagram- and podcast-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE) will be shared on Tuesdays, Thursdays, and Sundays and saved as highlights. In addition, one educational podcast episode developed for the intervention will be delivered weekly via Instagram direct message every Friday. All content will be provided at the same time each day throughout the intervention period.

Primary Outcomes

  • Breast Cancer Awareness Scale (Assessments will be performed at baseline and Week 8.)
  • Champion's Health Belief Model Scale in Breast Cancer Screening (Assessments will be performed at baseline and Week 8.)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-07-06
Completion: 2026-12-31
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: true
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ankara University
Principal Investigators:
  • Baise Bicav (PRINCIPAL_INVESTIGATOR) - Yüksek İhtisas University
  • Zehra Bicav (PRINCIPAL_INVESTIGATOR) - Yüksek İhtisas University
  • Sevinç Kutlutürkan (STUDY_DIRECTOR) - Ankara University
Contact Information
Study Contact:
Baise BİCAV
0 312 329 10 10
baisebicav@gmail.com
Zehra BİCAV
0 312 329 10 10
Interventions
  • Other: Instagram-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy" Instagram account and receive an 8-week Instagram-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE), such as "Do not forget to perform your monthly BSE" and "Remember to perform BSE this week," will be shared on Tuesdays, Thursdays, and Sundays. Stories will also be saved as highlights. No content will be shared on Fridays, and all posts and stories will be published at the same time each day.
  • Other: Instagram-Podcast-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy Plus" Instagram account and receive an 8-week Instagram- and podcast-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE) will be shared on Tuesdays, Thursdays, and Sundays and saved as highlights. In addition, one educational podcast episode developed for the intervention will be delivered weekly via Instagram direct message every Friday. All content will be provided at the same time each day throughout the intervention period.
Study Locations (1 sites)
Ankara, Ankara, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Women aged 20-39 years * Able to read and write Turkish * Turkish citizens * Have an active Instagram account and access it at least once daily * No previous diagnosis of cancer * Willing to participate and provide informed consent Exclusion Criteria: * No access to a smartphone with the Instagram application * Visual, hearing, or cognitive impairment that may prevent participation in the intervention Withdrawal Criteria: * Failure to complete the assigned podcast sessions during the intervention period * Participant request to withdraw from the study at any time
A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
NCT03332797
Active, positions filled
Conditions Breast Cancer
Phase PHASE1
Enrollment 181
Locations 23 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

Design

Study type: Interventional Phases: Phase1 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: GDC-9545 — GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
  • Drug: Palbociclib — Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
  • Drug: LHRH Agonist — The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.

Primary Outcomes

  • Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) (From Baseline until 28 days after the last dose of study treatment (up to 84 months))
  • Dose Escalation: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of GDC-9545 When Administered as a Single Agent or in Combination with Palbociclib (Days -7 to 28 of Cycle 1)
  • Dose Escalation: Number of Participants with Dose-Limiting Toxicities When GDC-9545 is Administered as a Single Agent or in Combination with Palbociclib (Days -7 to 28 of Cycle 1)
  • Change from Baseline in Systolic Blood Pressure Over Time (Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment)
  • Change from Baseline in Diastolic Blood Pressure Over Time (Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment)
  • Change from Baseline in Body Temperature Over Time (Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment)
  • Change from Baseline in Pulse Rate Over Time (Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment)
  • Change from Baseline in Respiration Rate Over Time (Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2017-11-24
Completion: 2027-07-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 181 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Genentech, Inc.
Principal Investigators:
  • Clinical Trials (STUDY_DIRECTOR) - Hoffmann-La Roche
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: GDC-9545 — GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
  • Drug: Palbociclib — Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
  • Drug: LHRH Agonist — The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.
Study Locations (23 sites)
University of Colorado, Aurora, Colorado 80045 United States
Massachusetts General Hospital., Boston, Massachusetts 02115 United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Vanderbilt University Medical Center, Nashville, Tennessee 37204 United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales 2010 Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria 3000 Australia
National Cancer Center, Gyeonggi-do, 410-769 South Korea
Seoul National University Hospital, Seoul, 03080 South Korea
Eligibility Criteria
Inclusion Criteria for Dose Escalation: * Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent or with metastatic disease * Estrogen receptor (ER)-positive tumor * Human epidermal growth factor receptor 2 (HER2)-negative breast cancer as per local laboratory testing * Measurable disease, or evaluable bone disease; that is, bone lesions that are lytic or mixed (lytic + sclerotic) in the absence of measurable lesion * Required paired pre- and on-treatment tumor biopsies for participants with metastases that are safely accessible as determined by the investigator * Advanced or metastatic ER-positive/HER2-negative breast cancer that has recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months and/or endocrine therapy in the incurable, locally advanced, or metastatic setting and derived a clinical benefit from therapy (i.e., tumor response or stable disease for at least 6 months) * No more than 2 prior lines of treatment for advanced or metastatic breast cancer * Greater than or equal to (≥)2 weeks must have elapsed from the use of any other endocrine, targeted therapy or chemotherapy * Single-Agent Cohorts (only applies to Dose Escalation): Advanced or metastatic disease that is either refractory to or intolerant of existing standard therapy or for which no effective standard therapy that confers clinical benefit is available * Cohort B0: No prior treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor * For participants undergoing 18F-fluoroestradiol-positron emission tomography (FES-PET) imaging additional restrictions on prior therapy include: ≥2 months must have elapsed from the use of tamoxifen; ≥6 months must have elapsed from the use of fulvestrant * Postmenopausal status * Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (≤)1 * Resolution of all acute toxic effects of prior therapy or surgical procedures to baseline or Grade ≤1 (except alopecia or other toxicities not considered to be a safety risk for the patient) * Life expectancy of ≥12 weeks * Adequate organ function Inclusion Criteria for Dose Expansion: Same criteria as above for Dose Escalation, except for those that only apply to Dose Escalation, plus the following: * Required paired pre- and on-treatment tumor biopsies for participants in Cohorts A1-A5, B1, and B2 with metastases that are safely accessible as determined by the investigator * In South Korea: Must have received exactly 2 prior lines of treatment for advanced or metastatic breast cancer * In the rest of the world: No more than 1 prior line of treatment for advanced or metastatic breast cancer (not applicable to Cohort X) Plus the following criteria: * Cohorts B1 and B2: No prior treatment with CDK4/6 inhibitor * Cohorts A1, A3, A5, B1, C1, and C2 only: Postmenopausal status * Cohorts A2, A4, and B2 only: Participants not defined as postmenopausal; Age less than (\<)56 years who have medical menopause on LHRH agonist (on stable dose ≥4 weeks) * No prior treatment with an oral selective estrogen receptor degrader (SERD) * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods with a failure rate of \<1% per year during the treatment period and for 10 days after the last dose of GDC-9545 and 21 days after the last dose of palbociclib, and agreement to refrain from donating eggs during this same period * Cohort X only: Participants enrolled on Studies GO29656 or GO29642 and received clinical benefit from GDC-0927 or GDC-0810 * Hematology, chemistry, and urinalysis collected 72 hours before Cycle 1, Day 1 deemed acceptable for dosing by the investigator * No other endocrine therapy, targeted therapy, or chemotherapy after last dose of GDC-0927 or GDC-0810 Exclusion Criteria for Dose Escalation: * Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms * Current treatment with any systemic anti-cancer therapies for advanced disease (not applicable to Cohort X participants currently receiving GDC-0810 or GDC-0927) * Concurrent treatment with warfarin or phenytoin * Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer * Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection * Known human immunodeficiency virus (HIV) infection * Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (e.g., hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis * Major surgery within 4 weeks prior to enrollment * Radiation therapy within 2 weeks prior to enrollment * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Inability or unwillingness to swallow tablets or capsules (only applies to Dose Escalation) * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study (only applies to Dose Escalation) * History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction * QT interval corrected using Fridericia's formula (QTcF) greater than (\>)470 milliseconds (ms) demonstrated by at least two ECGs \>30 minutes apart * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease coronary heart disease clinically significant electrolyte abnormalities or family history of sudden unexplained death or long QT syndrome * Current treatment with medications that are well known to prolong the QT interval Exclusion Criteria for Dose Expansion: Same criteria as above for Dose Escalation, except for those that only apply to Dose Escalation, plus the following criteria: * Pregnant, lactating, or breastfeeding * Additional exclusion criteria for Cohort B (Phase 1b cohort): History of venous thromboembolic event requiring therapeutic anticoagulation * Additional exclusion criteria for Cohorts C1 and C2 only: Current treatment with medications that are well known to decrease heart rate, including beta blockers
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
NCT06926920
Recruiting
Conditions Triple Negative Breast Cancer
Phase PHASE1, PHASE2
Enrollment 100
Locations 16 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Sacituzumab Govitecan-hziy (SG) — Administered intravenously

Primary Outcomes

  • Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) (First dose up to 28 days)
  • Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs) (First dose up to 30 days post last dose (Up to 3 years))
  • Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities (First dose up to 30 days post last dose (Up to 3 years).)
  • Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations (First dose up to 30 days post last dose (Up to 3 years).)
  • Phases 1 and 2: Objective Response Rate (ORR) (Up to 9 months)
  • Phase 2: Progression-Free Survival (PFS) (Up to 9 months)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-04-30
Completion: 2028-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Gilead Sciences
Principal Investigators:
  • Gilead Study Director (STUDY_DIRECTOR) - Gilead Sciences
Contact Information
Study Contact:
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
Interventions
  • Drug: Sacituzumab Govitecan-hziy (SG) — Administered intravenously
Study Locations (16 sites)
Los Angeles Cancer Network (LACN) - Good Sam, Los Angeles, California 90017 United States
Winship Cancer Institute - Emory University, Atlanta, Georgia 30322 United States
The University of Kansas Hospital, Westwood, Kansas 66205 United States
Siteman Cancer Center, St Louis, Missouri 63110 United States
West Cancer Centre, Germantown, Tennessee 38138 United States
SCRI Oncology Partners, Nashville, Tennessee 37203 United States
Tennessee Oncology, PLLC, Nashville, Tennessee 37203 United States
Texas Oncology - DFW, Dallas, Texas 75246 United States
Virginia Oncology Associates, Norfolk, Virginia 23502 United States
St. Vincent's Hospital - Kinghorn Cancer Center, Darlinghurst, New South Wales 2010 Australia
Eligibility Criteria
Key Inclusion Criteria: * Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent. * Histologically or cytologically locally confirmed TNBC. * Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease. * Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease. * Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) \< 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity. * Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status. During Phase 1 safety run-in, individuals must be UGT1A1 wild-type. After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible. * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate hematologic counts within 2 weeks prior to enrollment. * Adequate hepatic and renal function. Key Exclusion Criteria: * Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor. * Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. Note: Other protocol defined Inclusion/Exclusion criteria will apply.
SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer
NCT07109284
Not yet recruiting
Conditions ER+HER2- Breast Cancer
Phase PHASE2
Enrollment 55
Locations 0 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Biological: Sacituzumab tirumotecan — Sacituzumab tirumotecan 5 mg/kg, intravenously (iv), Q2W
  • Biological: Tagitanlimab — Tagitanlimab 900mg, intravenously (iv), Q2W

Primary Outcomes

  • Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0) (Up to approximately 6 months (Time of surgery))
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2025-09
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 55 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: West China Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Biological: Sacituzumab tirumotecan — Sacituzumab tirumotecan 5 mg/kg, intravenously (iv), Q2W
  • Biological: Tagitanlimab — Tagitanlimab 900mg, intravenously (iv), Q2W
Eligibility Criteria
Inclusion Criteria: 1. Females aged 18-70 years; 2. Pathologically confirmed invasive ductal breast cancer and untreated previously； 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 4. Life expectancy ≥3 months; 5. Have at least 1 measurable disease defined by RECIST v1.1; 6. T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2; 7. Has confirmed ER+/HER2-：ER≥1%、HER2 IHC 0、1+ or 2+/ISH-）; 8. Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10% 9. Tissue or blood available for biomarker assessment; 10. Adequate organ function; 11. Patients with negative serum pregnancy test and those with fertility potential must agree to use effective contraception during the treatment period and for at least 3 months after the last dose of study drugs; 12. Patients must voluntarily participate in this study, sign an informed consent form, exhibit good compliance, and be willing to cooperate with follow-up procedures； Exclusion Criteria: 1. Inflammatory BC； 2. Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast). 3. Has bilateral invasive breast cancer. 4. Has metastatic (stage IV) breast cancer. 5. Has left ventricular ejection fraction (LVEF) of \<50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening. 6. Has received prior treatment for breast cancer. 7. Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, CD137). 8. Has received prior treatment for targeting TROP2 and/or topoisomerase I; 9. Patients who have had other malignancies within the past five years will be excluded from the study, with exceptions for those who have been successfully treated for cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma of the skin; 10. Has hypersensitivity to any of the components or excipients used in the study treatments. 11. History of allogeneic organ transplantation; 12. Patients with a history of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, those currently diagnosed with ILD or non-infectious pneumonia, or those with suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging at the time of screening, will be excluded. Additionally, patients suffering from clinically severe pulmonary damage due to pulmonary comorbidities will also be excluded. This includes, but is not limited to, any underlying pulmonary disease (such as pulmonary embolism within the past three months, severe asthma, advanced chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory conditions potentially affecting the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), as well as those who have undergone a pneumonectomy. 13. Patients with active autoimmune diseases requiring systemic treatment within the past two years will be excluded from the study. Systemic treatment does not include hormone replacement therapy, such as insulin therapy for Type 1 Diabetes, thyroid hormone replacement for hypothyroidism, or physiological doses of glucocorticoids for adrenal or pituitary insufficiency. 14. Patients with active infection requiring systemic therapy. 15. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to high blood pressure beyond the control of drugs, serious diabetes, active infection, etc. 16. Patients for whom participation in the study was deemed to be inappropriate by the investigator for any other reason were also excluded.
Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
NCT07145255
Recruiting
Conditions Prostate Cancer Castration-resistant Pro...
Phase PHASE1, PHASE2
Enrollment 150
Locations 7 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Non Randomized Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: ADC — MBRC-201 ADC

Primary Outcomes

  • Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) (From Enrollment through treatment and long term follow-up (approximately 24 months))
  • • Incidence and prevalence of Dose-limiting Toxicities (DLTs) and cumulative safety by dose level (21 days)
  • Duration of Response (DOR) (Approximately 24 months)
  • Disease Control Rate (DCR) (Approximately 24 months)
  • Progression Free Survival (PFS) (Approximately 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-09-03
Completion: 2029-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: MBrace Therapeutics
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: ADC — MBRC-201 ADC
Study Locations (7 sites)
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94158 United States
START, Midwest, Grand Rapids, Michigan 49546 United States
START, Astera, East Brunswick, New Jersey 08816 United States
NEXT, Dallas, Irving, Texas 75039 United States
START San Antonio, San Antonio, Texas 78229 United States
START, Mountain Region, West Valley City, Utah 84119 United States
NEXT, Virginia, Fairfax, Virginia 22031 United States
Eligibility Criteria
Inclusion Criteria: Patients are eligible to be included in the study only if all of the following criteria apply: 1. Provide written consent on an informed consent form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures. 2. 18 years of age or older at the time of informed consent. 3. Female patients must be at least 2 years postmenopausal (defined as 2 years without menses), surgically sterile (at least 6 months prior to dosing; must be documented) or patients of childbearing potential under the following conditions: * Must be nonlactating and have a negative serum (preferred) or urine pregnancy test results within 72 hours prior to the first dose of MBRC-201. * Must agree not to try to become pregnant during the study and for at least 6 months after the final dose of MBRC-201 * Must agree to practice effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) and willing to continue to use effective contraception for the duration of study participation and for 6 months after the final dose of study drug. 4. Male patients whose partners are of childbearing potential must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) (Section 10.4) for the duration of study participation and for 6 months after the final dose of study drug. 5. Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard-of-care treatment options known to confer a clinical benefit or for which the patient is ineligible or declines (except for Phase 1b-Cohort A). A. For Phase 1a dose escalation: Patients must have one of the following tumor types: i. mCRPC, breast cancer (TNBC, HR+/HER2-negative or HER2-low, HR-/HER2+), CRC, NSCLC, or PDAC B. For Phase 1b: Patients must have one of the following tumor types: i. Cohort A: Histologic or cytologic diagnosis of mCRPC (with confirmed adenocarcinoma histology) refractory to standard treatment. Patients must have had prior exposure to at least one novel AR-targeted therapy (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide). Prior taxane or lutetium Lu 177 vipivotide tetraxetan is acceptable but not required. ii. Cohort B: Histologic or cytologic diagnosis of advanced metastatic NSCLC refractory to standard treatment. iii. Cohort C: Histologic or cytologic diagnosis of advanced metastatic breast cancer (TNBC, HR+/HER2-negative or HER2-low, HR-/HER2+) refractory to standard treatment. iv. Cohort D: Histologic or cytologic diagnosis of advanced metastatic CRC, PDAC refractory to standard treatment. The Sponsor may add or remove specific tumor indications based on emerging, real-time study results. 6. Availability of a tumor tissue sample (formalin-fixed paraffin-embedded \[FFPE\]) must be confirmed if feasible. Patients without tumor sample may be eligible with medical monitor approval. Tumor biopsies are not required and should not be performed to assess eligibility. 7. For Dose Escalation (Phase 1a), patients may have evaluable disease or measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. For both Dose Expansion (Phase 1b) and Phase 2, patients must have measurable disease according to RECIST v1.1 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 9. Life expectancy ≥ 3 months 10. Patient must have adequate organ and marrow function as defined below. * Absolute neutrophil count (ANC) ≥ 1500/uL * Hemoglobin (Hgb) ≥ 9 g/dL * Platelet count ≥ 100,000/uL * International normalized ratio (INR) \< 1.5 (or ≤ 3.0 if on therapeutic anticoagulation) * Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection * Total bilirubin ≤ 1.5 × ULN \[or ≤ 3-times ULN for patients with Gilbert's disease or documented hepatic tumor involvement\] * ALT and AST ≤ 3 × ULN \[or ≤ 5-times ULN for patients with documented hepatic tumor involvement\] Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Allowed exceptions are patients with: 1. Non-melanoma skin cancer considered completely cured; 2. Localized prostate cancer treated with curative intent with no evidence of progression; 3. Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat; 4. Malignancy that is otherwise considered cured with minimal risk of recurrence. 2. Known or suspected sensitivity to any of the ingredients of the investigational product MBRC-201. 3. Active cerebral/meningeal disease related to the underlying malignancy. Patients with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the patient is clinically stable. (defined as not having received steroid treatment for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to the first dose of study drug and with no ongoing related AEs). 4. Any uncontrolled viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug, unless deemed not clinically significant by the investigator (e.g., onychomycosis). Routine antimicrobial prophylaxis is permitted. 5. Active or symptomatic viral hepatitis, including patients with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients who have been treated for hepatitis C infection or who have spontaneously recovered are permitted. 6. Patients with HIV infection with 1 or more of the following: * Acquired immunodeficiency syndrome (AIDs)-defining opportunistic infection within 6 months of the start of screening * A change in antiretroviral therapy within 3 months of the start of screening and viral load \> 500 copies/mL * Receiving antiretroviral therapy that may interfere with study drug * CD4 count \< 350 at screening 7. Thromboembolic events and/or bleeding disorders ≤ 14 days (e.g., venous thromboembolism \[VTE\] or pulmonary embolism \[or PE\]) prior to the first dose of study drug 8. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug 9. A baseline QT (time from the beginning of the Q wave to the end of the T wave) interval as corrected by Fridericia's formula (QTcF) \> 470 msec or patients with risk factors for Torsades de pointes 10. Uncontrolled Inflammatory Bowel Disease (IBD) 11. A history of (non-infectious) ILD/pneumonitis requiring steroid therapy, or active ILD/pneumonitis, or clinically suspected ILD/pneumonitis that cannot be ruled out by imaging at screening 12. Uncontrolled autoimmune disease or syndrome 13. Active ocular surface disease at screening, including confluent superficial keratitis, cornea epithelial defect, corneal ulcer or stromal opacity or any components of the ophthalmologic history which, in the investigator's opinion, may place the patient at significant risk. Cataracts alone are not an exclusion criterion. 14. Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy,
Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer
NCT06856499
Recruiting
Conditions Endometrioid Ovarian Cancer, Primary Per...
Phase PHASE1
Enrollment 50
Locations 2 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy. If a participant is a good fit for the study, and they enroll in the study, they will: * Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days. * Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.

Design

Study type: Interventional Phases: Phase1 Allocation: Non Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Cirtuvivint — Cirtuvivint (SM08502) is a first in class pan CDC-like kinase (CLK) and dual specificity tyrosine kinase (DYRK) inhibitor with suspected multiple anti-tumor mechanisms of action, including Wnt inhibition.
  • Drug: Olaparib — NCI Definition - A small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse tumor cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks.

Primary Outcomes

  • Determine the Safety of Combination Cirtuvivint with Olaparib (6 months)
  • Determine the recommended Phase 2 Dose of Cirtuvivint with Olaparib (6 months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-12-08
Completion: 2030-09-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Principal Investigators:
  • Bradley Corr (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Kailey Palmen, BA
303-724-2435
kailey.palmen@cuanschutz.edu
Interventions
  • Drug: Cirtuvivint — Cirtuvivint (SM08502) is a first in class pan CDC-like kinase (CLK) and dual specificity tyrosine kinase (DYRK) inhibitor with suspected multiple anti-tumor mechanisms of action, including Wnt inhibition.
  • Drug: Olaparib — NCI Definition - A small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse tumor cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks.
Study Locations (2 sites)
CU Medicine Clinics, Aurora, Colorado 80045 United States
Universtiy of Colorado Hospital, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Woman aged ≥18 years of age 4. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2 5. Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer 6. Patients must have platinum-resistant disease defined as radiographic progression less than 6 months from last dose of most recent platinum therapy 7. Patients must have measurable disease by defined RECIST 1.1 criteria 8. Prior anticancer therapy: * Patients must have received at least one prior platinum-based chemotherapy regimen * Patients may not have received more than 3 prior lines of systemic therapy * Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently) * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently) * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance * Prior radiation is allowed and is not considered a line of treatment 9. Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRD testing, and have been positive for one and/or the other. 10. Patients must have received a prior PARP inhibitor as either treatment or maintenance therapy 11. Patients must have adequate hematologic, liver, and kidney function as defined as: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL) * Platelet count ≥ 100 x 109/L (100,000 µL) * Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) * Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN) * Serum albumin ≥ 2 g/dL 12. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 13. Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible. Exclusion Criteria: 1. Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal type ovarian tumor 2. Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy 3. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment 4. Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia. 5. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to: * Uncontrolled major seizure disorder * Unstable spinal cord compression * Any psychiatric disorder that prohibits obtaining informed consent. * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of therapy 6. Patients with clinically significant cardiac disease including, but not limited to, any of the following * Myocardial infarction ≤ 6 months prior to first dose * Uncontrolled ventricular arrhythmia, recent (within 3 months) * Superior vena cava syndrome * Unstable angina pectoris * Uncontrolled congestive heart failure (New York Heart Association \> class II) * Uncontrolled ≥ Grade 3 hypertension (per CTCAE) * Uncontrolled cardiac arrhythmias 7. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment 8. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C) 9. Persistent toxicities (\>/= Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensory neuropathy 10. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication o Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication 11. Patients with known untreated or symptomatic central nervous system (CNS) metastases 12. Prior known hypersensitivity reaction to study drugs and/or any of their excipients 13. Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 14. Inability to comply with study and follow-up procedures 15. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
NCT06418204
Recruiting
Conditions Breast Carcinoma, Colorectal Carcinoma, ...
Phase Not Applicable
Enrollment 2000
Locations 467 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Non-interventional Study — Non-interventional study

Primary Outcomes

  • Cancer-related symptoms (Baseline and re-assessed monthly up to 12 months post-enrollment)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-01-30
Completion: 2028-08-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Glenn Lesser, MD (STUDY_CHAIR) - Wake Forest University Health Sciences
Contact Information
Study Contact:
Karen Craver
336-716-0891
NCORP@wfusm.edu
Interventions
  • Other: Non-interventional Study — Non-interventional study
Study Locations (467 sites)
Fairbanks Memorial Hospital, Fairbanks, Alaska 99701 United States
Kingman Regional Medical Center, Kingman, Arizona 86401 United States
Cancer Center at Saint Joseph's, Phoenix, Arizona 85004 United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas 72903 United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas 72401 United States
Kaiser Permanente-Deer Valley Medical Center, Antioch, California 94531 United States
Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California 93420 United States
PCR Oncology, Arroyo Grande, California 93420 United States
Mercy Cancer Center - Carmichael, Carmichael, California 95608 United States
Mercy San Juan Medical Center, Carmichael, California 95608 United States
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified). * Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment. * Participants must be able to comprehend English or Spanish (for survey completion). * Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location. * Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment. * Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey * In the treating provider's opinion, the participant should have a life expectancy of \>=6 months. Participants in hospice are not eligible. Optional Sub-study (available at select sites only): * Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU). * Must be receiving treatment at the WF CCC and VCU. * Must be diagnosed with non-small cell lung cancer. * Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4. Exclusion Criteria: * Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms. * Participants with known pregnancy. * Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy. * Participants enrolled in hospice. Optional Substudy (available at select sites only): * Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed. * Participants with a history of HIV, hepatitis B or hepatitis C.
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
NCT04266249
Active, positions filled
Conditions Anatomic Stage II Breast Cancer AJCC v8,...
Phase PHASE2
Enrollment 2175
Locations 1008 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

Design

Study type: Interventional Phases: Phase2 Allocation: Non Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Docetaxel — Given IV
  • Procedure: Lumpectomy — Undergo lumpectomy
  • Procedure: Mastectomy — Undergo mastectomy
  • Drug: Nab-paclitaxel — Given IV
  • Drug: Paclitaxel — Given IV
  • Biological: Pertuzumab — Given IV
  • Radiation: Radiation Therapy — Undergo radiation therapy
  • Biological: Trastuzumab — Given IV

Primary Outcomes

  • Recurrence-free survival (RFS) (Up to 3 years after end of treatment)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2020-03-13
Completion: 2038-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2175 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Nadine M Tung (PRINCIPAL_INVESTIGATOR) - ECOG-ACRIN Cancer Research Group
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Docetaxel — Given IV
  • Procedure: Lumpectomy — Undergo lumpectomy
  • Procedure: Mastectomy — Undergo mastectomy
  • Drug: Nab-paclitaxel — Given IV
  • Drug: Paclitaxel — Given IV
Study Locations (1008 sites)
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233 United States
Anchorage Associates in Radiation Medicine, Anchorage, Alaska 98508 United States
Anchorage Radiation Therapy Center, Anchorage, Alaska 99504 United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska 99508 United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska 99508 United States
Alaska Women's Cancer Care, Anchorage, Alaska 99508 United States
Anchorage Oncology Centre, Anchorage, Alaska 99508 United States
Katmai Oncology Group, Anchorage, Alaska 99508 United States
Providence Alaska Medical Center, Anchorage, Alaska 99508 United States
Fairbanks Memorial Hospital, Fairbanks, Alaska 99701 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma, determined by local testing. The tumor must have either HER2 IHC result of 3+ or HER2/CEP17 ratio \> 2 with \> 4.0 HER2 signals per cell by ISH. Tumors with HER2/CEP17 ISH ratio \< 2 are ineligible, even if HER2 copy number is \> 6, unless HER2 IHC result is 3+. * Patients hormone receptor (estrogen receptor \[ER\] and progesterone receptor \[PR\]) status must be known and will be determined by local testing. Patients with either hormone receptor -positive or hormone receptor- negative HER2-positive breast cancer are eligible * Patients must have AJCC 8th Edition stage II or IIIa according to anatomic staging table at diagnosis * Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-3) * Patients with nodal involvement (cN1-2) are eligible if T1-3 * Patients with clinical T4 or N3 disease are not eligible * Patient must be willing and able (i.e., have no contraindication) to receive standard adjuvant therapy, consisting of HER2-directed therapy, radiation (if indicated) and endocrine therapy (if ER+) if achieving pCR at surgery * Patient with bilateral invasive breast cancers are eligible if both cancers are HER2-positive (as defined in 3.1.3) at least one meets protocol eligibility and neither cancer renders the patient ineligible (i.e. per eligibility 3.1.5) * Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive, and at least one tumor focus meets eligibility criteria (per eligibility 3.1.5). Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. However, even if biopsy is not deemed necessary, consideration should be given to placing a clip in any lesion that is 1 cm or further from the primary tumor to ensure that all tumor is removed at surgery AND that the pathologist can locate all primary sites of tumor to assess pathologic response at surgery. * Patients with a history of other non-breast malignancies are eligible if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy. * Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, and localized papillary or follicular thyroid cancer who have completed recommended treatment including surgery. Patients with any other cancers within the last 5 years are ineligible. * Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or \> 50%) * Patients must not have \> grade 1 peripheral neuropathy of any etiology. * Patients must have a bilateral mammogram and a diagnostic breast ultrasound \[on the side of the cancer(s)\] (with or without breast MRI) performed at screening. An axillary ultrasound on the side of the cancer(s) is also required. However, if a patient has a negative axillary physical exam and a baseline MRI without suspicious lymph nodes performed before axillary ultrasound, axillary ultrasound may be omitted. Comprehensive breast and axillary imaging must be performed within 42 days of registration (i.e. the patient's mammogram/ breast ultrasound /axillary ultrasound OR their breast MRI). * Baseline imaging of the ipsilateral axilla by ultrasound or breast MRI is mandatory. For subjects with axillary lymph node(s) suspicious on clinical exam or imaging, patient must be willing to have a needle aspiration or core biopsy to determine the presence of metastatic disease in the lymph nodes. A clip must be placed in the involved axillary lymph node. (If there are more than 1 suspicious axillary nodes, only one clipped node is required). * Patient of childbearing potential and sexually active patients must use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 7 months after the last dose of study treatment. * Patient must be willing and able to sign informed consent * Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to protocol registration) * Absolute neutrophil count \>= 1,500/mcL (obtained =\< 28 days prior to protocol registration) * Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol registration) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 28 days prior to protocol registration) * Creatinine =\< 1.5 x institutional ULN (obtained =\< 28 days prior to protocol registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Exclusion Criteria: * Patients must not have impaired decision-making capacity * Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer * One exception: a patient with a history of T1N0 triple negative breast cancer diagnosed more than 10 years earlier, who remains disease free is eligible * Patient must not have prior ipsilateral ductal breast carcinoma in situ (DCIS). Patients with prior lobular breast carcinoma in situ (LCIS), atypical hyperplasia, other high risk benign lesions or contralateral DCIS (without evidence of microinvasion) are eligible * NOTE: Patients currently receiving endocrine therapy for prior contralateral DCIS are eligible * Patient must not have stage IV (metastatic) breast cancer * Staging studies (computed tomography \[CT\] chest/abdomen/pelvis and a bone scan or positron emission tomography \[PET\]-CT scan) are required for stage III disease or those with abnormal baseline liver function tests (LFTs), symptoms (e.g. new bone pain) or abnormal physical exam findings (National Comprehensive Cancer Network \[NCCN\] guidelines version \[V\]1.2019) * Patient must not have T4 and/or N3 disease, including inflammatory breast cancer * Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy * Patients must not have \> grade 1 peripheral neuropathy of any etiology * Patient must not have a concurrent serious medical condition that would preclude completion of study therapy. For example, uncontrolled hypertension (systolic \> 180 mm Hg and/or diastolic \> 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to registration, unstable angina, congestive heart failure (CHF) or serious cardiac arrhythmia requiring medication and other concurrent serious diseases that may interfere with planned treatment * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 7 months after the last dose of study tr
Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy
NCT07189884
Not yet recruiting
Conditions Locally Advanced Breast Cancer (LABC)
Phase PHASE1, PHASE2
Enrollment 33
Locations 0 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Imaging evaluation was performed according to RECIST 1.1 criteria, and tumor imaging evaluation was performed by the participating center. The pathological evaluation after surgery of neoadjuvant patients was the pCR assessed by the pathologist of the participating center.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine — Pyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle. Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28). Endocrine therapy: The endocrine therapy drug is selected by the investigator.

Primary Outcomes

  • ORR (6 month)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Not yet recruiting
Start Date: 2025-09-23
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 33 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The First Affiliated Hospital of Xiamen University
Contact Information
Study Contact:
Shuanglong Chen
15618959221850
1868012@qq.com
Interventions
  • Drug: Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine — Pyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle. Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28). Endocrine therapy: The endocrine therapy drug is selected by the investigator.
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged ≥18 years and ≤75 years old, who have just been treated for breast cancer; 2. Pathological examination confirmed that HR was positive (ER≥10%) and HER2 was low (immunohistochemical staining ICH++ and FISH negative); 3. Patients with invasive breast cancer confirmed by pathological examination (T≥3 or N≥1) who are eligible for neoadjuvant therapy; 4. ECOG score 0\~1 points; 5. Planned to undergo definitive surgical resection of breast cancer, i.e., breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy, or axillary lymph node dissection (ALND); 6. Normal function of major organs, i.e. meeting the following criteria: (1) Blood routine examination standards must meet: ANC ≥1.5×109/L; PLT ≥90×109/L； Hb ≥90g/L； (2) Biochemical examination must meet the following criteria: TBIL ≤upper limit of normal (ULN); ALT and AST ≤ 1.5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN), BUN and Cr ≤ 1.5× ULN and creatinine clearance ≥ 50 mL/min (CockcroftGault formula); (3) Cardiac color ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) 18-lead ECG corrected by Fridericia's QT interval (QTcF) in women\< 470 ms; 7. For female patients who are not menopausal or surgically sterilized: agree to abstain from sexual activity or use an effective contraceptive method during the treatment period and for at least 7 months after the last dose of study treatment; 8. Volunteer to join this study and sign the informed consent form. Exclusion Criteria: 1. Those who have a known history of allergy to the drug components of this regimen; 2. Previous anti-tumor therapy or radiotherapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma); 3. Underwent major surgical procedures unrelated to breast cancer within 4 weeks, or patients have not fully recovered from such surgical procedures; 4. Patients with stage IV (metastatic) breast cancer; 5. Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption; 6. Severe heart disease or discomfort that cannot be treated; 7. Suffering from mental illness or psychotropic substance abuse and unable to cooperate; 8. Pregnant or lactating female patients; 9. Patients with severe liver and kidney function diseases and hematological diseases; 10. Those who are not suitable for enrollment in the investigator's opinion: such as a history of drug abuse, blood products, anticoagulant drugs and immunological drugs in the past year; Those with poor compliance and refusal to cooperate with treatment; Doctors with severe hypertension and diabetes are not suitable for the study.
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
NCT06144164
Recruiting
Conditions Lymphedema, Lymphedema Arm, Lymphedema o...
Phase PHASE3
Enrollment 285
Locations 7 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.

Design

Study type: Interventional Phases: Phase3 Allocation: Intervention model: Single Group Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Procedure: Immediate Lymphatic Reconstruction — Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
  • Diagnostic Test: Volumetric arm measurements — Volumetric arm measurements will occur at each in-person postoperative visit time points.
  • Other: Lymphatic massage — Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
  • Other: Range of motion exercises — Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
  • Other: Compression garment use — Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed

Primary Outcomes

  • The difference between the baseline and postoperative arm volume measurement (Up to 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2023-11-16
Completion: 2030-03-16
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 285 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Michelle Coriddi, MD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
Study Contact:
Michelle Coriddi, MD
646-608-8042
coriddim@mskcc.org
Babak Mahrara, MD
646-608-8085
mehrarab@MSKCC.ORG
Interventions
  • Procedure: Immediate Lymphatic Reconstruction — Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection
  • Diagnostic Test: Volumetric arm measurements — Volumetric arm measurements will occur at each in-person postoperative visit time points.
  • Other: Lymphatic massage — Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
  • Other: Range of motion exercises — Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed
  • Other: Compression garment use — Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed
Study Locations (7 sites)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York 10065 United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York 11553 United States
Eligibility Criteria
Inclusion Criteria: * Female sex * Diagnosis of breast cancer * Ages 18 to 75 years * Consented for unilateral ALND or for unilateral SLNB with possible ALND Exclusion Criteria: * Male sex * Does not speak English * Does not fit into study garment * Axillary recurrence * History of ALND * Requirement of bilateral ALND for the treatment of breast cancer * Treatment with SLNB only * Known anaphylactic allergy to ICG dye used in ILR * Impaired decision-making capacity
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
NCT06401421
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 1800
Locations 58 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis. Participants will be followed for up to 5.5 years.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Diagnostic Test: ctDNA MRD test — Blood and tissue samples will be collected for the ctDNA MRD test

Primary Outcomes

  • Core biopsy tissue evaluability rate (3 years)
  • Distant Recurrence Free Interval (dRFI) (6 years)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-06-07
Completion: 2030-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1800 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Exact Sciences Corporation
Collaborators: NSABP Foundation Inc
Contact Information
Study Contact:
NSABP Department of Site and Study Management Department of Site and Study Management
1-800-270-3165
industry.trials@nsabp.org
Interventions
  • Diagnostic Test: ctDNA MRD test — Blood and tissue samples will be collected for the ctDNA MRD test
Study Locations (58 sites)
Katmai Oncology Group - Anchorage, Anchorage, Alaska 99508 United States
Stanford Cancer Institute, Palo Alto, California 94304 United States
Harbor-UCLA Medical Center - Hematology / Oncology, Torrance, California 90502 United States
Kaiser Permanente Medical Center, Vallejo, California 94589 United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center, Aurora, Colorado 80045 United States
AdventHealth East Altamonte Oncology and Hematology, Altamonte Springs, Florida 32701 United States
Mount Sinai Medical - Comprehensive Cancer Center, Miami Beach, Florida 33140 United States
Baptist Cancer Care - Plantation, Plantation, Florida 33324 United States
St. Joseph's Women's Hospital, Tampa, Florida 33607 United States
Rush Cancer Center, Chicago, Illinois 60607 United States
Eligibility Criteria
Inclusion Criteria: 1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry. 2. The participant must be ≥ 18 years of age. 3. ECOG performance status 0 or 1. 4. Histologically confirmed invasive carcinoma of the breast. 5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy. 6. Tumor size ≥ 2.1 cm in greatest diameter. 7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype. 8. Clinically node positive or if node negative, any one of the following: 1. TNBC or HER2+ subtype 2. HR+/HER2-negative with at least one of the following: i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.) 9. Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw. 10. Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay. Exclusion Criteria: 1. Definitive clinical or radiologic evidence of metastatic disease. 2. Initiated neoadjuvant therapy for current breast cancer diagnosis. 3. Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers. 4. Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment. 5. Completed all therapy for any previous hematologic malignancy \< 5 years ago. 6. Multicentric or contralateral invasive breast cancers. 7. Known pregnancy at time of enrollment. 8. Prior solid organ transplant. 9. Prior allogeneic hematopoietic stem cell transplant.
Effects of Expectations and Body Image in Breast Reconstruction
NCT04714463
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually benefit from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Procedure: Implant-based breast reconstruction — All types of implant based breast reconstructions
  • Procedure: Autologous breast reconstruction — All types of autologous breast reconstructions
  • Procedure: Combined methods — All types of breast reconstructions combining autologous and implant based techniques

Primary Outcomes

  • Patient satisfaction with breast reconstruction measured with Breast Q reconstruction (2 years)
  • Patient expectations measured with Breast Q expectations (2 years)
  • Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS) (2 years)
  • Body image investment measured with Appearance schemas inventory-revised (ASI-R) (2 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2021-02-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vastra Gotaland Region
Principal Investigators:
  • Emma Hansson, PhD (PRINCIPAL_INVESTIGATOR) - Göteborg University
Contact Information
Study Contact:
Emma Hansson, PhD
+46313421000
emma.em.hansson@vgregion.se
Interventions
  • Procedure: Implant-based breast reconstruction — All types of implant based breast reconstructions
  • Procedure: Autologous breast reconstruction — All types of autologous breast reconstructions
  • Procedure: Combined methods — All types of breast reconstructions combining autologous and implant based techniques
Study Locations (1 sites)
Sahlgrenska university hospital, Gothenburg, 413 45 Sweden
Eligibility Criteria
Inclusion Criteria: * Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction * Age \> 18 years Exclusion Criteria: * Inability to give informed consent * Inability to understand Swedish * Relaps of cancer * Palliative treatment
DESTINY Breast Respond HER2-(Ultra)Low Europe
NCT05945732
Recruiting
Conditions Unresectable Breast Cancer, Metastatic B...
Phase Not Applicable
Enrollment 2295
Locations 216 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
View Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Based on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Interventions / Regimen

  • Drug: Trastuzumab deruxtecan — This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. Trastuzumab (T-DXd) to be administered according to the SmPC. Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.

Primary Outcomes

  • Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer (Baseline up to approximately 37 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-10-24
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2295 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Principal Investigators:
  • Global Team Leader (STUDY_DIRECTOR) - Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Contact Information
Study Contact:
Contact for Clinical Trial Information
908-992-6400
CTRinfo@dsi.com
Interventions
  • Drug: Trastuzumab deruxtecan — This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. Trastuzumab (T-DXd) to be administered according to the SmPC. Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.
Study Locations (216 sites)
Medizinische Universität Graz, Graz, 8036 Austria
Medizinische Universität Graz, Graz, 8036 Austria
Medizinische Universität Innsbruck, Innsbruck, 6020 Austria
Klinikum Klagenfurt am Wörthersee, Klagenfurt, 9020 Austria
LKH Hochsteiermark-Leoben, Leoben, 8700 Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, 4010 Austria
Interne II, LKH Feldkirch, Rankweil, 6830 Austria
KH der Barmherzigen Brüder Salzburg, Salzburg, 5010 Austria
Uniklinikum Salzburg, Salzburg, 5020 Austria
Medical University of Vienna, Vienna, 1090 Austria
Eligibility Criteria
Inclusion Criteria: Study Group 1 and Study Group 2 * Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC * Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC * Written and signed Informed Consent to participate in the study Study Group 1 * Documented HER2-low status (IHC1+, IHC2+/ISH-) * Patients who have received prior chemotherapy in the metastatic setting or * Patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy Study Group 2: * Documented HR+ status * Documented HER2-low status (IHC1+ or IHC2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining \[IHC \> 0 to \<1+\]) status * Patients who have received at least one endocrine therapy in the metastatic setting * Patients who have NOT received prior chemotherapy in the metastatic setting Exclusion Criteria: Study Group 1 and Study Group 2 * Pregnancy or breastfeeding * Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded. No other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.