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Showing 20 of 27881 trials
Tomosynthesis Mammographic Imaging Screening Trial
NCT02616432
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 3065
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

A randomized screening trial to compare the diagnostic accuracy of screening for breast cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional full-field digital mammography (FFDM) versus FFDM alone.

Design

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

Interventions / Regimen

  • Device: Tomosynthesis — Three-dimensional imaging of both breasts in standard CC and MLO views

Primary Outcomes

  • Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison (3 year follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2014-10
Completion: 2027-12
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: true
Enrollment: 3065 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Sunnybrook Health Sciences Centre
Collaborators: Eastern Cooperative Oncology Group
Principal Investigators:
  • Roberta A Jong, MD (PRINCIPAL_INVESTIGATOR) - Sunnybrook Health Sciences Centre
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Tomosynthesis — Three-dimensional imaging of both breasts in standard CC and MLO views
Study Locations (4 sites)
X-Ray 505 (Under the BCCA Screening Mammography Program of BC), Vancouver, British Columbia V5Z 1H4 Canada
Breast Health Centre at BC Women's Hospital + Health Centre, Vancouver, British Columbia V6H 3N1 Canada
The Ottawa Hospital, Ottawa, Ontario K1Y 4E9 Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5 Canada
Eligibility Criteria
Inclusion Criteria: * Asymptomatic women age 40 and over * Scheduled for screening mammogram * Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol * Willing and able to provide a written informed consent. Exclusion Criteria: * Presenting for mammography with symptoms of breast disease * Have new breast complaints (e.g. lump, nipple discharge) * Have had a mammogram of both breasts within the last 11 months * Previous personal history of breast cancer * Has breast enhancements (e.g. implants or injections) * Pregnancy or intent to become pregnant.
Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
NCT04438681
Active, positions filled
Conditions Triple Negative Breast Cancer
Phase Not Applicable
Enrollment 90
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.

Design

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

Primary Outcomes

  • Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC) (8 years)
  • Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC) (8 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2020-11-27
Completion: 2029-11-09
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Jean Perrin
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Centre Jean PERRIN, Clermont-Ferrand, 63011 France
Eligibility Criteria
Inclusion Criteria: * Female * Age \> 18 years * Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer * Patient able to understand the French language * Patient affiliated to social security * Obtaining signed written consent Exclusion Criteria: * Persons deprived of their freedom or under guardianship or incapable of giving consent * Refusal to participate
The Application Value of Spectral CT in the Accurate Staging of Breast Cancer
NCT06977412
Not yet recruiting
Conditions Breast Adenocarcinoma
Phase NA
Enrollment 150
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

Spectral CT was used to prospectively collect medical images and clinical data related to breast cancer, evaluate the effect of image quality in the diagnosis of breast cancer, and evaluate the application value in the accurate staging of breast cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.

Design

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

Interventions / Regimen

  • Diagnostic Test: To explore the value of spectral CT in the diagnosis and treatment of breast cancer — The CT scan is part of the standard treatment protocol.

Primary Outcomes

  • Pathological TNM staging (1 day)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-06-01
Completion: 2026-05-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yunnan Cancer Hospital
Principal Investigators:
  • Lianhua Ye (STUDY_DIRECTOR) - Ethics Committee of Yunnan Provincial Cancer Hospital
Contact Information
Study Contact:
Caiyang Li
13658700171
2020429049@kmmu.edu.cn
Zhenhui Li
13698736132
lizhenhui@kmmu.edu.cn
Interventions
  • Diagnostic Test: To explore the value of spectral CT in the diagnosis and treatment of breast cancer — The CT scan is part of the standard treatment protocol.
Eligibility Criteria
Inclusion Criteria: * (a) Chest quark energy spectrum CT examination was performed within 1 week before treatment * (b) Age ≥ 18 * (c) Suspected breast cancer patients * (d) Patients who signed informed consent Exclusion Criteria: * (a) Severe cardiac, pulmonary and renal insufficiency * (b) Allergic to iodine contrast media * (c) Unable to cooperate to complete CT examination * (d) Quark spectrum CT image is poor and cannot be used * (e) Male, pregnant and lactating female * (f) Combined with other tumor history * (g) Incomplete clinical and pathological data * (h) Pathologically confirmed non breast cancer
Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda
NCT07562399
Not yet recruiting
Conditions Medication Adherence, Breast Cancer
Phase NA
Enrollment 224
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

This study aims to evaluate a multi-modal intervention designed to improve adherence to adjuvant endocrine therapy (AET) among patients with ER-positive breast cancer in Rwanda. The intervention includes educational, behavioral, and reminder components, and will be assessed for feasibility and impact on medication adherence.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: Educational video — One-time educational video
  • Behavioral: Symptom monitoring card — Symptom monitoring card
  • Behavioral: Text reminders — Weekly one-way text reminders

Primary Outcomes

  • 3-month Adherence Rate (3 months)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-09-20
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 224 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Principal Investigators:
  • Temidayo Fadelu, MD (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
Study Contact:
Temidayo Fadelu, MD
617-632-3779
temidayo_fadelu@dfci.harvard.edu
Interventions
  • Behavioral: Educational video — One-time educational video
  • Behavioral: Symptom monitoring card — Symptom monitoring card
  • Behavioral: Text reminders — Weekly one-way text reminders
Study Locations (4 sites)
Brigham and Women's Hospital, Boston, Massachusetts 02053 United States
Boston Children's Hospital, Boston, Massachusetts 02115 United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02215 United States
Butaro Cancer Center of Excellence, Butaro, RN8 02053 Rwanda
Eligibility Criteria
Inclusion Criteria: * Female patients * Age 18 or older * Pathologic confirmation of ER-positive breast cancer * Clinical or radiographic confirmation of disease localized to the breast and regional lymph nodes * Within 6-36 months of starting AET * Have a cellphone capable of receiving text messages. * Are currently receiving AET at Butaro or satellite clinics. Exclusion Criteria: * Unwilling/Unable to participate * Unable to comprehend study languages (English or Kinyarwanda) * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
NCT06790264
Recruiting
Conditions Breast Cancer Invasive, Node Positive Br...
Phase NA
Enrollment 92
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.

Design

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

Interventions / Regimen

  • Procedure: 68Ga-FAPi-46 PET/CT — Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT

Primary Outcomes

  • Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate (3 months)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-01
Completion: 2025-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 92 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: European Institute of Oncology
Principal Investigators:
  • Francesco Ceci, MD (PRINCIPAL_INVESTIGATOR) - European Istitute of Oncology
Contact Information
Study Contact:
Francesco Ceci
+390257489315
francesco.ceci@ieo.it
Interventions
  • Procedure: 68Ga-FAPi-46 PET/CT — Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
Study Locations (1 sites)
European Institute of Oncology, Milan, Italy 20141 Italy
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed, biopsy proven breast cancer; * Diagnosis of invasive breast cancer; * Tumor diameter more than 2 centimeters; * Radiological evidence of axillary nodes involvement; * 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up; * 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT; * Patients suitable to primary treatment (surgery or neo-adjuvant therapy); * 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment; * Female patients; * Age ≥18; * Willing to sign informed consent form. Exclusion Criteria: * Pregnant or nursing patients; * Unable to stay flat and cannot tolerate PET scan; * Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression; * Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
NCT06562192
Recruiting
Conditions Pancreatic Ductal Adenocarcinoma, Non-sm...
Phase PHASE1
Enrollment 162
Locations 29 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Design

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

Interventions / Regimen

  • Drug: [68Ga]Ga-NNS309 — Radioligand imaging agent
  • Drug: [177Lu]Lu-NNS309 — Radioligand therapy

Primary Outcomes

  • Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 (From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule)
  • Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309 (From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months)
  • Dose modifications for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks)
  • Dose intensity for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2024-10-15
Completion: 2031-01-16
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 162 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Novartis Pharmaceuticals
Contact Information
Study Contact:
Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
+41613241111
novartis.email@novartis.com
Interventions
  • Drug: [68Ga]Ga-NNS309 — Radioligand imaging agent
  • Drug: [177Lu]Lu-NNS309 — Radioligand therapy
Study Locations (29 sites)
Uni of Alabama at Birmingham, Birmingham, Alabama 35249 United States
University of California LA, Los Angeles, California 90095 United States
Stanford University Medical Center, Palo Alto, California 94304 United States
Mayo Clinic Jacksonville, Jacksonville, Florida 32224 United States
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
BAMF Health, Grand Rapids, Michigan 49503 United States
Mayo Clinic Rochester, Rochester, Minnesota 55905 United States
Uni Of TX MD Anderson Cancer Cntr, Houston, Texas 77030 United States
University Of Washington, Seattle, Washington 98109 United States
Novartis Investigative Site, Brussels, 1000 Belgium
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Patients with one of the following indications: * Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy * (Dose escalation part only) Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy * Patients must have lesions showing 68Ga-NNS309 uptake Exclusion Criteria: * Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 109/L * QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec * Creatinine clearance \< 60 mL/min * Unmanageable urinary tract obstruction or urinary incontinence * Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-NNS309 Other protocol-defined inclusion/exclusion criteria may apply.
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
NCT06165900
Recruiting
Conditions Stereotactic Radiotherapy, Immunotherapy...
Phase PHASE2
Enrollment 136
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.

Design

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

Interventions / Regimen

  • Drug: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) — Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles.
  • Drug: adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) — adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

Primary Outcomes

  • tpCR (6 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2023-09-26
Completion: 2028-12-15
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 136 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shengjing Hospital
Contact Information
Study Contact:
Caigang Liu, Dr.
18940254967
liucg@sj-hospital.org
Nan Niu, Dr.
18940256668
niunannancy@163.com
Interventions
  • Drug: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) — Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles.
  • Drug: adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) — adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
Study Locations (1 sites)
Shengjing Hospital of China Medical University, Shenyang, Liaoning 110022 China
Eligibility Criteria
Inclusion Criteria: * Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years; * Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \< 1%, PR negative: IHC \< 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; * Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1; * ECOG score 0-1; * Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist; * Appropriate level of organ function * Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol. Exclusion Criteria: * Patients with metastatic breast cancer or bilateral breast cancer; * Patients with inflammatory breast cancer or occult breast cancer; * Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization; * Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors; * Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial. * Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ; * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test) * Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
NCT03157128
Active, positions filled
Conditions Non-Small Cell Lung Cancer, Medullary Th...
Phase PHASE1, PHASE2
Enrollment 857
Locations 85 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Design

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

Interventions / Regimen

  • Drug: LOXO-292 — Oral LOXO-292

Primary Outcomes

  • Phase 1: Maximum Tolerated Dose (MTD) (Cycle 1 (cycle length = 28 days))
  • Phase 1: Recommended Phase 2 Dose (RP2D) (Cycle 1 (cycle length = 28 days))
  • Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment (Approximately for up to 7 years 8 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2017-05-02
Completion: 2027-02
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 857 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Eli Lilly and Company
Collaborators: Loxo Oncology, Inc.
Principal Investigators:
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) (STUDY_DIRECTOR) - Eli Lilly and Company
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: LOXO-292 — Oral LOXO-292
Study Locations (85 sites)
Mayo Clinic of Scottsdale, Scottsdale, Arizona 85259 United States
City of Hope National Medical Center, Duarte, California 91010-0269 United States
UCLA Medical Center, Los Angeles, California 90095 United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92663 United States
Kaiser Permanente, Oakland, California 94611-5400 United States
Irvine Medical Center, Orange, California 92868 United States
University of California - San Diego, San Diego, California 92103 United States
UCSF Medical Center at Mission Bay, San Francisco, California 94158 United States
Kaiser Permanente Medical Center, Walnut Creek, California 94596 United States
Sarah Cannon Research Institute at HealthOne, Denver, Colorado 80218 United States
Eligibility Criteria
Key Inclusion Criteria: For Phase 1: * Participants with a locally advanced or metastatic solid tumor that: * Has progressed on or is intolerant to standard therapy, or * For which no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or * Decline standard therapy * Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed * A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation * Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type * Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) greater than or equal to (≥) 40 percent (%) (age less than \[\<\] 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment * Adequate hematologic, hepatic and renal function * Life expectancy of at least 3 months For Phase 2: As for phase 1 with the following modifications: * For Cohort 1: Participants must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy * Cohorts 1 and 2: * Enrollment will be restricted to participants with evidence of a RET gene alteration in tumor * At least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated * Cohorts 3 and 4: Enrollment closed * Cohort 5: * Cohorts 1-4 without measurable disease * MCT not meeting the requirements for Cohorts 3 or 4 * MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval * cfDNA positive for a RET gene alteration not known to be present in a tumor sample * Cohort 6: Participants who otherwise are eligible for Cohorts 1, 2 or 5 who discontinued another RET inhibitor may be eligible with prior Sponsor approval * Cohort 7: Participants with a histologically confirmed stage IB-IIIA NSCLC and a RET fusion; determined to be medically operable and tumor deemed resectable by a thoracic surgical oncologist, without prior systemic treatment for NSCLC Key Exclusion Criteria (Phase 1 and Phase 2): * Phase 2 Cohorts 1 and 2: an additional known oncogenic driver * Cohorts 3 and 4: Enrollment closed * Cohorts 1, 2 and 5: prior treatment with a selective RET inhibitor Notes: Participants otherwise eligible for Cohorts 1, 2, and 5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval * Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292 (selpercatinib). In addition, no concurrent investigational anti-cancer therapy is permitted Note: Potential exception for this exclusion criterion will require a valid scientific justification and approval from the Sponsor * Major surgery (excluding placement of vascular access) within 2 weeks prior to planned start of LOXO-292 (selpercatinib) * Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of LOXO-292 (selpercatinib), with the exception of participants receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy * Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Participants are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 (selpercatinib) and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS) * Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 (selpercatinib) or prolongation of the QT interval corrected (QTcF) greater than (\>) 470 milliseconds (msec) * Participants with implanted pacemakers may enter the study without meeting QTc criteria due to nonevaluable measurement if it is possible to monitor for QT changes. * Participants with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia's and if it is possible to monitor for QT changes. * Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and certain prohibited concomitant medications * Phase 2 Cohort 7 (neoadjuvant treatment): Participant must not have received prior systemic therapy for NSCLC.
A Single-arm, Prospective, Multi-center Cohort Study Based on Deep Learning-based cfDNA Fragment Omics to Verify the TuFEst Model for the Staging Diagnosis of Breast Cancer Lesions and Lymph Nodes
NCT07304934
Not yet recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 269
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Through the research of this project, we expect to achieve the cfDNA fragment omics liquid biopsy technology based on deep learning, verify the accuracy of the TuFEst model in predicting the tumor burden status of breast cancer lesions and lymph nodes in newly diagnosed breast cancer patients and those receiving neoadjuvant therapy, and provide a theoretical basis for large-scale clinical application in the future

Design

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

Interventions / Regimen

  • Other: No Intervention: Observational Cohort — No Intervention: Observational Cohort

Primary Outcomes

  • Negative predictive value (NPV) of the TuFEst-based classifier for predicting pathologic node-negative status (pN0) (up to 2 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-12-01
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 269 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: No Intervention: Observational Cohort — No Intervention: Observational Cohort
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 70; 2. Direct Surgery Group (Cohort 1) : Radical surgery was performed without neoadjuvant therapy; 3. Neoadjuvant therapy group (Cohort 2) : The initial diagnosis was invasive breast cancer with confirmed axillary lymph node metastasis, and the patient was willing to undergo radical surgery at the end of treatment; 4. Plasma from patients during treatment can be obtained; 5. Be willing to sign the informed consent form. - Exclusion Criteria: 1. Be pregnant or breastfeeding; 2. Patients whose lesions have been resected; 3. Suffered from other types of malignant tumors with a clear pathological diagnosis within 5 years prior to enrollment; 4. Within the past year of enrollment, the patient had other malignant tumors suspected by imaging, but they were not confirmed by pathology; 5. Suspected distant metastatic lesions on imaging, or potential lymph node lesions that cannot be completely cured by surgery; 6. Have received any blood product infusion treatment in the past 30 days. -
Evaluating an AI-Based Mobile Application for Chemotherapy Support in Breast Cancer Patients
NCT07273812
Recruiting
Conditions Breast Cancer, Breast Neoplasm, Chemothe...
Phase NA
Enrollment 130
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn if an Arabic-language mobile application that uses artificial intelligence (AI) can help women with breast cancer during chemotherapy. The app is designed to give personalized support by reminding participants about their medications, teaching them how to manage treatment side effects, and alerting their healthcare team about serious symptoms. The main questions this study aims to answer are: 1. Does the AI-based mobile app provide accurate and safe recommendations for the patients? 2. Does using the AI-based mobile app help lower treatment-related symptoms and side effects compared to usual care? 3. Does the app help participants take their medications more regularly? 4. Does it increase participants' understanding and satisfaction with the information they receive about their treatment? Researchers will compare two groups: Group 1: Participants who use the AI-based mobile app plus usual oncology care. Group 2: Participants who receive usual care only. Participants will: 1. Use the mobile app daily for 12 weeks while receiving chemotherapy. 2. Complete short questionnaires about symptoms, medication use, and quality of life at the start and end of the study. 3. Report any problems or feedback about using the app. The AI app is for support and education only. It does not make treatment decisions. All information from the app will be reviewed by oncologists and pharmacists to ensure participant safety.

Design

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

Interventions / Regimen

  • Behavioral: AI-Based Mobile Application for Personalized Chemotherapy Support — The intervention is an Arabic-language mobile application powered by artificial intelligence (AI) designed to provide personalized chemotherapy support for women with breast cancer. The app assists participants by monitoring symptoms, sending medication adherence reminders, and offering educational content on managing side effects and improving treatment understanding. It uses a conversational interface based on natural language processing (NLP) to communicate with users. Participants are asked to use the app daily for 12 weeks while receiving chemotherapy. A human-in-the-loop system ensures oncologists and pharmacists review AI-generated advice for accuracy and safety.
  • Other: Usual Care — Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.

Primary Outcomes

  • Change in Symptom Burden and Chemotherapy-Related Toxicities (Arabic PRO-CTCAE) (Up to 12 weeks)
  • Medication Adherence Score (Arabic MMAS-8 (Baseline and at weeks 6,12.)
  • Change in Patient Knowledge and Information Satisfaction (EORTC QLQ-INFO25) (Baseline and at weeks 6,12.)
  • Change in General Quality of Life (EORTC QLQ-C30) (Baseline and at weeks 6,12.)
  • Change in Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23) (Baseline and at weeks 6,12.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-06-01
Completion: 2026-11-06
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dena h. Al-Tameemi
Collaborators: Baghdad Medical City
Principal Investigators:
  • Samer Imad Mohammed, Assistant Prof (PRINCIPAL_INVESTIGATOR) - University of Baghdad-College of Pharmacy
Contact Information
Study Contact:
Dena A. Al-Tameemi, MSc.
+9647901572647
dina.abbas2400p@copharm.uobaghdad.edu.iq
Samer Imad Mohammed, PhD
Samer.jameel@copharm.uobag
Interventions
  • Behavioral: AI-Based Mobile Application for Personalized Chemotherapy Support — The intervention is an Arabic-language mobile application powered by artificial intelligence (AI) designed to provide personalized chemotherapy support for women with breast cancer. The app assists participants by monitoring symptoms, sending medication adherence reminders, and offering educational content on managing side effects and improving treatment understanding. It uses a conversational interface based on natural language processing (NLP) to communicate with users. Participants are asked to use the app daily for 12 weeks while receiving chemotherapy. A human-in-the-loop system ensures oncologists and pharmacists review AI-generated advice for accuracy and safety.
  • Other: Usual Care — Standard oncology care provided by the hospital team, including chemotherapy administration, routine follow-up, and patient education according to local protocols.
Study Locations (1 sites)
Oncology Teaching Hospital-Medical City- Baghdad, Baghdad, Iraq
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of breast cancer stages I, II, or III. * Patients must be currently scheduled to initiate their first-ever cycle of chemotherapy. * Age 18 years or older. * Ability to understand and provide informed consent. * Possession of a smartphone (Android or iOS) and functional digital literacy, defined as the ability to independently navigate mobile applications, read on-screen text in Arabic, and input daily health data. (for the intervention group). * Willingness to comply with study procedures and follow-up schedules. * Ability to communicate in Arabic, as the mobile application and chatbot will be developed in Arabic. Exclusion Criteria: * Patients with Stage IV (Metastatic) breast cancer. * Patients receiving concurrent hormonal therapy during the chemotherapy phase, to isolate chemotherapy-induced adverse events. Patients with cognitive impairment or severe psychiatric disorders that would preclude effective interaction with the mobile application or questionnaire completion. * Patients receiving palliative care where symptom management is the sole focus and active chemotherapy is not being administered with curative or life prolonging intent. * Patients participating in other interventional clinical trials that might confound the outcomes of this study. * Patients with severe comorbidities that could significantly impact their ability to participate or bias outcome measures.
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
NCT06259929
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 51
Locations 8 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: * To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 * To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response; * To evaluate the safety of abemaciclib and giredestrant. Exploratory objectives: * To evaluate the mechanisms of response and resistance to therapy; * To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction; * To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

Design

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

Interventions / Regimen

  • Drug: Abemaciclib 150 MG + Giredestrant 30 MG — Enrolled patients will receive 6 cycles of treatment in the absence of disease progression or unacceptable toxicity for a total of 24 weeks (2 weeks of opportunity phase and 22 weeks of neoadjuvant phase) before surgery

Primary Outcomes

  • Efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate (Week 2)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-01-27
Completion: 2027-04-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 51 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fondazione Oncotech
Principal Investigators:
  • Michelino De Laurentiis, MD (PRINCIPAL_INVESTIGATOR) - National Cancer Institute, Naples
Contact Information
Study Contact:
Michelino De Laurentiis, MD
08117770442
m.delaurentiis@istitutotumori.na.it
Claudia Von Arx, MD
0815903565
Claudia.vonarx@istitutotumori.na.it
Interventions
  • Drug: Abemaciclib 150 MG + Giredestrant 30 MG — Enrolled patients will receive 6 cycles of treatment in the absence of disease progression or unacceptable toxicity for a total of 24 weeks (2 weeks of opportunity phase and 22 weeks of neoadjuvant phase) before surgery
Study Locations (8 sites)
Humanitas Istituto Clinico Catanese, Catania, Catania 95045 Italy
IRCCS Ospedale Policlinico San Martino, Genova, Genova 16132 Italy
AOU Federico II, Naples, Napoli 80131 Italy
Istituto Nazionale Tumori "G. Pascale", Naples, Napoli 80131 Italy
Istituto Oncologico Veneto IRCCS, Padova, Padova 35128 Italy
IRCCS Centro di Riferimento Oncologico (CRO), Aviano, PN 33081 Italy
Fondazione Universitaria Policlinico Gemelli IRCCS, Roma, Roma 00168 Italy
Ospedale Fatebenefratelli - Isola Tiberina, Roma, Roma 00186 Italy
Eligibility Criteria
Inclusion Criteria: 1. Female patients willing and able to give written informed consent; 2. Women≥18 years of age; 3. Postmenopausal women, as defined by at least one of the following criteria: * ≥12 months of amenorrhea without an alternate medical cause plus follicle-stimulating hormone (FSH) and plasma estradiol levels within postmenopausal range by local laboratory assessment, in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone agonist or antagonist. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; * Documented bilateral oophorectomy (≥ 14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline); 4. Patients with cT1c (≥1.0 cm)-cT4a-c BC at presentation; a-c primary tumor must be ≥ 1.0 cm in longest diameter by ultrasound; 5. Confirmed ER+ disease by local testing on primary disease specimen: tumor must be ER ≥ 10% defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing; 6. Confirmed HER2- disease by local testing on primary disease specimen: tumor must be HER2- according to ASCO/CAP 2023 guidelines for HER2 testing; 7. Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathologic criteria for ER positivity and HER2 negativity. 8. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy; 9. Patients considered appropriate for endocrine therapy according to physician judgment; 10. Ki67 score ≥10% analyzed locally and centrally confirmed. Ki67 will be analyzed locally at the time of inclusion. Patients with basal Ki67≥20% will be assessed locally and centrally confirmed retrospectively and patients with 10-19% will be assessed centrally before inclusion. 11. Patients with breast cancer eligible for primary surgery; 12. Eastern Cooperative Oncology Group (ECOG) performance status≤1; 13. Adequate bone marrow and coagulation and adequate organ function defined as follows: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; * Platelets count ≥100x 109/L; * Haemoglobin ≥9 g/dL (90 g/L); * Serum creatinine≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance≥60 ml/min as calculated using the standard method for the institution; * Total serum bilirubin ≤1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits could be included); * AST and/or ALT ≤3 x ULN; * Alkaline phosphatase ≤2.5 x ULN; 14. Patients able to swallow oral medications. Exclusion Criteria: 1. Patients with bilateral invasive BC; 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1\_cN2a); 3. Patients with inflammatory BC; 4. Non post-menopausal patients; 5. Patients having received previous systemic or local treatment for BC, in particular history of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors; 6. Participants who have active cardiac disease or history of cardiac dysfunction, including any of the following: * History (within 2 years of screening) or presence of idiopathic bradycardia or resting heart rate \< 50 beats per minute at screening * History of angina pectoris or symptomatic coronary heart disease within 12 months prior to randomization * History of documented congestive heart failure (New York Heart Association Class III or IV) or cardiomyopathy * QT interval corrected through use of Fridericia's formula \>470 ms for women \> 450 ms for men based on mean value of triplicate ECGs, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes * Presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or sick sinus syndrome o Participants with first-degree heart block may be considered for inclusion following consultation with a cardiologist and determination that no additional cardiac risks are present. * Participants with pacemakers to treat more severe heart blocks and other arrhythmias are permitted. * Patients with history of well-controlled atrial fibrillation are eligible. * History (within 12 months) or presence of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as significant structural heart disease (e.g., severe left ventricular systolic dysfunction, restrictive cardiomyopathy, hypertrophic cardiomyopathy, infiltrative cardiomyopathy, moderate-to-severe valve disease), or family history of long QT syndrome) o Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia) should be corrected prior to enrollment. 7. Patients with known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis; 8. Patients with history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ and other malignancy within 5 years prior to screening; 9. Patients with documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism; 10. Patients on concurrent treatment with exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate); 11. Patients with active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]; 12. Patients with serious and/or uncontrolled pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study, e.g. interstitial lung disease (ILD), severe dyspnoea at rest requiring oxygen therapy, severe renal impairment (i.e. estimated creatinine clearance \<30 ml/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea); 13. Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients; 14. Patients with history of non-compliance to medical regimens; 15. Patients refusing to perform liquid and tissue biopsy; 16. Patients unwilling to or unable to comply with the protocol; 17. Patients having had major surgery within 14 days prior to screening; 18. Pregnant or lactating females prior to treatment; 19. Patients having received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to initiation of study treatment, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study; 20. Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer:a Multi-center, Multi-cohort Phase II Trial
NCT06636981
Recruiting
Conditions Triple Negative Breast Cancer (TNBC)
Phase PHASE2
Enrollment 129
Locations 2 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

All trans retinoic acid Combined with Toripalimab+Chemotherapy for Locally Advanced inoperable or Metastatic Triple Negative Breast Cancer:a multi-center, multi-cohort phase II trial

Design

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

Interventions / Regimen

  • Drug: Cohort2: ATRA+Toripalimab+TPC — Receive 200 mg D1 of Toripalimab via intravenous infusion for a course of 21 days; TPC regimen (monoclonal antibody 10mg/kg D1, 8 intravenous infusions, 1 course of treatment every 21 days; Elibulin 1.4mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Utideron 40mg/m2 D1-5 intravenous infusions, 1 course of treatment every 21 days; Gemcitabine 1000mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Albumin paclitaxel 100 mg/m2 D1, D8, intravenous infusion, 1 course of treatment every 21 days); Capecitabine 1000mg/m2, D1-14, oral, one course of treatment every 21 days); All trans retinoic acid 20 mg bid, orally, D-3-D11, administered continuously for 14 days, stopped for 7 days, with one course of treatment lasting 21 days.
  • Drug: Cohort1: ATRA+Toripalimab+chemo — Receive 200 mg of Toripalimab via D1 intravenous infusion, with 21 days as one course of treatment; Albumin paclitaxel 100 mg/m2, D1, D8, intravenous infusion, one course of treatment for 21 days; All trans retinoic acid 20 mg bid, oral, D-3-D11, continuous administration for 14 days, cessation for 7 days, 21 days is one course of treatment.

Primary Outcomes

  • Objective Response Rate (ORR) (up to 2 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-11-04
Completion: 2029-09
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 129 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Contact Information
Study Contact:
Zhonghua Tao, MD
86 13774315805
drtaozhh@126.com
Interventions
  • Drug: Cohort2: ATRA+Toripalimab+TPC — Receive 200 mg D1 of Toripalimab via intravenous infusion for a course of 21 days; TPC regimen (monoclonal antibody 10mg/kg D1, 8 intravenous infusions, 1 course of treatment every 21 days; Elibulin 1.4mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Utideron 40mg/m2 D1-5 intravenous infusions, 1 course of treatment every 21 days; Gemcitabine 1000mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Albumin paclitaxel 100 mg/m2 D1, D8, intravenous infusion, 1 course of treatment every 21 days); Capecitabine 1000mg/m2, D1-14, oral, one course of treatment every 21 days); All trans retinoic acid 20 mg bid, orally, D-3-D11, administered continuously for 14 days, stopped for 7 days, with one course of treatment lasting 21 days.
  • Drug: Cohort1: ATRA+Toripalimab+chemo — Receive 200 mg of Toripalimab via D1 intravenous infusion, with 21 days as one course of treatment; Albumin paclitaxel 100 mg/m2, D1, D8, intravenous infusion, one course of treatment for 21 days; All trans retinoic acid 20 mg bid, oral, D-3-D11, continuous administration for 14 days, cessation for 7 days, 21 days is one course of treatment.
Study Locations (2 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Fudan University Shanghai Cancer Center, Shanghai, China
Eligibility Criteria
Inclusion Criteria: 1. The subjects voluntarily participate and sign a written informed consent form; 2. Age ≥ 18 years old; 3. For locally advanced inoperable or metastatic breast cancer confirmed by histology (according to AJCC 8th edition staging), the histology and pathology clearly showed that ER, PR, Her-2 were negative. If there was metastatic lesion pathology, the metastatic lesion histology and pathology should prevail. The definition of ER and PR negativity is: IHC ER\&amp;lt;1%, IHC PR\&amp;lt;1%. Her-2 negativity is defined as: immunohistochemical detection of Her-2 (-) or (1+), Her-2 (2+) must undergo FISH testing and the result is negative, Her-2 (-) or (1+) can choose to undergo FISH testing and the result is negative; 4. According to RECIST 1.1 criteria for solid tumor evaluation, there must be at least one measurable lesion; 5. Cohort 1: For locally advanced non operable or metastatic TNBC that has not been previously treated, intravenous chemotherapy and anti-tumor therapy may be used during previous neoadjuvant and/or adjuvant therapy stages, provided that the interval between the end of neoadjuvant and/or adjuvant therapy and the occurrence of recurrence/metastasis is ≥ 12 months; Cohort 2: Local late stage inoperable or metastatic TNBC with previous treatment failures of at least one line or above; 6. All subjects should undergo tumor lesion biopsy during the screening period to obtain sufficient qualified tumor tissue specimens for retrospective biomarker analysis (including PD-L1 expression levels) in their cohort. If subjects are unable to undergo biopsy, they should provide tumor samples or unstained sections (3-5 μm) that have been fixed in formalin and embedded in paraffin (FFPE) closest to the start of the study treatment (up to 24 months) for corresponding biomarker analysis; 7. The main organ function is good, the relevant examination indicators within 14 days before treatment meet the following requirements: Without blood transfusion, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 90g/L, neutrophil count (ANC) ≥ 1.5 × 10\^9/L AST and ALT ≤ 2.5 x upper limit of normal (ULN), ≤ 5 x ULN if liver metastasis is present, total bilirubin ≤ 1.5 x ULN, serum creatinine (Cr) ≤ 1.5 ULN, or creatinine clearance rate ≥ 60mL/min (Cockcroft Gault formula) 8. Expected survival period ≥ 3 months; 9. ECOG PS score: 0-1 points; 10. Non surgical sterilization, male patients with women of childbearing age or partners of childbearing age, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 6 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours prior to enrollment in the study. Exclusion Criteria: 1. Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies; Participants in cohort 1 who have previously used albumin paclitaxel; 2. Individuals known to be allergic to any of the drugs in the study; 3. Patients who have hypersensitivity reactions to other vitamin A drugs; 4. History of active autoimmune diseases requiring systemic treatment in the past 2 years (e.g. corticosteroids (dose ≤ 10mg/day, except for prednisone or other effective hormones) or immunosuppressive drugs); 5. Diagnosed with immune deficiency or undergoing systemic steroid therapy (excluding doses ≤ 10mg/day of prednisone or other effective hormones) or any other form of immunosuppressive therapy within 7 days prior to enrollment; 6. There are other known malignant tumors that have progressed or require active treatment in the past 5 years. Excluding malignant tumors that can be treated locally and have already been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, and cervical cancer in situ; 7. Known to have active central nervous system (CNS) metastases; 8. History of non infectious pneumonia requiring steroid hormone therapy; 9. Active infections require systematic treatment; 10. There are serious uncontrolled hypertension, diabetes and hyperlipidemia; 11. History of II-IV congestive heart failure or myocardial infarction within 6 months prior to enrollment; 12. Individuals who tested positive for HIV during screening; 13. Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number\&amp;gt;upper limit of normal value); 14. Individuals with other serious acute or chronic physiological or mental problems; 15. Accepting any medication that is prohibited from being used in combination with the investigational drug, unless the medication has been discontinued within 7 days prior to enrollment; 16. Lactating women; 17. Individuals who have participated in clinical trials of other anti-tumor drugs within the past four weeks; 18. Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption; 19. Any situation that other researchers consider unsuitable for participation in this study.
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
NCT06176534
Recruiting
Conditions Advanced Breast Cancer, Treatment, HR Lo...
Phase PHASE2
Enrollment 240
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.

Design

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

Interventions / Regimen

  • Drug: Experimental: chemotheyapy — nab-paclitaxel 130mg/m2,day 1 and day 8 + Capecitabine 2000mg/m2, followed by nab-paclitaxel 130mg/m2,day 1 and day 8 or Capecitabine from day1 to DAY 14 Vinorelbine 25mg/m2,day 1 and day 8 + Capecitabine 2000mg/m2,from day1 to DAY 14
  • Drug: Active Comparator: endocrine therapy — palbociclib 125mg per day for 21days Dalpiciclib 150mg per day for 21days Letrozole 2.5mg per day Anastrozole 1mg per day fulvestrant 500mg per 28 days

Primary Outcomes

  • ORR by investigator using RECIST Guideline (Version 1.1) (6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-01-01
Completion: 2026-12-20
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 240 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Henan Cancer Hospital
Contact Information
Study Contact:
Min Yan, M.D.
+8615713857388
ym200678@126.com
Interventions
  • Drug: Experimental: chemotheyapy — nab-paclitaxel 130mg/m2,day 1 and day 8 + Capecitabine 2000mg/m2, followed by nab-paclitaxel 130mg/m2,day 1 and day 8 or Capecitabine from day1 to DAY 14 Vinorelbine 25mg/m2,day 1 and day 8 + Capecitabine 2000mg/m2,from day1 to DAY 14
  • Drug: Active Comparator: endocrine therapy — palbociclib 125mg per day for 21days Dalpiciclib 150mg per day for 21days Letrozole 2.5mg per day Anastrozole 1mg per day fulvestrant 500mg per 28 days
Study Locations (1 sites)
Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan China
Eligibility Criteria
Inclusion Criteria: 1. age ≥18 years old; Invasive breast cancer with metastatic disease confirmed by histological or cytological examination; Patients without pathologically or cytologically confirmed metastatic disease should have clear evidence of metastasis by physical examination or radiological studies; 2. The most recent pathological report of biopsy confirmed HR low expression and HER2 negative. 1. HR low expression was defined as 1-50% ER expression by immunohistochemistry (IHC); Or ER\<1% and PR≥1%; Patients with ER expression of 1-10% or ER-/ PR-positive patients were eligible for inclusion after careful evaluation by the investigator, and those with a small tumor burden and candidates for endocrine therapy were eligible. 2. HER2-negative definition: IHC 0 or 1+; If the IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH). 3. at least one measurable lesion; 4. No previous salvage chemotherapy for metastatic disease was required, and first-line endocrine therapy was allowed; 5. no previous CDK4/6 inhibitor; For adjuvant CDK4/6i treatment, recurrence and metastasis were required more than 1 year after drug withdrawal. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, life expectancy is more than 12 weeks; 7. Adequate function of major organs. 8. All adverse events recovered to grade 1 or less before enrollment (NCI CTCAE version 5.0); 9. patients without major organ dysfunction and heart disease; 10. Women and men of childbearing potential must agree to use appropriate contraception before and during study participation. Exclusion Criteria: 1. symptomatic, uncontrolled brain or leptomeningeal metastases; Patients who had received previous systemic radical treatment for brain metastases (radiotherapy or surgery), if stable disease had been maintained for at least 1 month as confirmed by imaging, and if systemic hormone therapy (dose 10mg/ day prednisone or other effective hormones) for more than 2 weeks without clinical symptoms. 2. patients received radiotherapy, chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before enrollment; Patients received endocrine therapy within 1 week before enrollment. Chemotherapy with nitrosourea or mitomycin was administered within 6 weeks before enrollment. 3. participated in other clinical trials of new drugs within 4 weeks before enrollment; 4. there can not be controlled by drainage or pneumatic methods third space effusion; 5. patients with other malignant tumors within the past 3 years, excluding radical cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 6. suffering from serious or uncontrolled diseases, including but not limited to: 1) active viral infection, such as HIV or HBV active (HbsAg positive and HBV-DNA≥103, hepatitis C antibody positive); 2) history of severe cardiovascular disease: uncontrolled hypertension; Myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. Patients with NYHA class ⅲ-ⅳ cardiac dysfunction, or left ventricular ejection fraction (LVEF) 50% by echocardiography; 3) severe infection (e.g., intravenous antibiotic, antifungal, or antiviral therapy according to clinical practice) within 4 weeks prior to the first dose or unexplained fever during screening/before the first dose; 38.3°C (fever due to cancer, as judged by the investigator, was eligible); 7. patients with a history of psychotropic drug abuse and unable to abstain or with mental disorders; Or accompanied by swallowing and absorption dysfunction; 8. patients with other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigators; 9. patients with known history of allergy to the components of this regimen; A history of immunodeficiency, including testing positive for HIV, HCV or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; 10. pregnant or lactating women; 11. Patients deemed unsuitable for inclusion by the investigators.
RCT of CBD for Anxiety in Advanced Breast Cancer
NCT04482244
Active, positions filled
Conditions Advanced Breast Cancer, Anxiety, CBD
Phase PHASE2
Enrollment 60
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: \- Cannabidiol (CBD)

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: Cannabidiol — Liquid taken orally
  • Other: Placebo — Liquid taken orally

Primary Outcomes

  • Change in Anxiety Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale (1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2022-01-19
Completion: 2026-12-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Collaborators: Hans and Mavis Lopater Foundation
Principal Investigators:
  • Ilana Braun, MD (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Cannabidiol — Liquid taken orally
  • Other: Placebo — Liquid taken orally
Study Locations (1 sites)
Dana Farber Cancer Institute, Boston, Massachusetts 02115 United States
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Stage IV or metastatic breast cancer * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%). * Participants must have adequate organ and marrow function at baseline as defined below: * total bilirubin \>2 times institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Baseline anxiety as measured by GAD-7 ≥5 * At least mild anxiety typically experienced prior to oncologic scans (as measured by a prescreen survey item) * Computed tomography (CT) or positron emission tomography (PET) to assess tumor burden scheduled for within 48 hours of study drug administration * No cannabis, delta-9-tetrahydrocannabinol or cannabidiol use within 24-hours of study drug administration. * No benzodiazepine consumption within 8 hours of study drug administration (e.g.,nighttime benzodiazepine use permissible) * No driving for 12 hours following study drug administration. * English proficiency * The effects of cannabidiol (Epidiolex) on the developing human fetus are unknown. For this reason and because cannabis is known to be teratogenic, women of child-bearing potential must test as nonpregnant prior to entering the study. The study team will encourage women of child-bearing age and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 1 week after cannabidiol (Epidiolex) consumption. Women either age \> 54 years or documented to be in menopause or status post hysterectomy will not be required to obtain bHCG. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cannabidiol (Epidiolex) or placebo (which contains sesame, corn and gluten) * History of current clobazam or valproic acid use * Current uncontrolled illness, for instance sepsis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia * Current use of antiretroviral therapy * Participants with psychiatric illness or social situations that would limit compliance with study requirements * Current hepatocellular carcinoma, or documented history of difficult to control diabetes -- Active participation in a clinical drug trial
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
NCT06625775
Recruiting
Conditions Solid Tumor, Adult, Metastatic Breast Ca...
Phase PHASE1
Enrollment 392
Locations 40 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Design

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

Interventions / Regimen

  • Drug: BBO-10203 — Participants will receive assigned dose of BBO-10203 orally once daily
  • Drug: Trastuzumab — Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
  • Drug: Fulvestrant — Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
  • Drug: Ribociclib — Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
  • Drug: FOLFOX — Patients will receive FOLFOX as infusion every 14 days
  • Drug: Bevacizumab — Patients will receive bevacizumab as infusion every 28 days

Primary Outcomes

  • Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent (Up to approximately 5 years)
  • Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (Up to approximately 5 years)
  • Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab (Up to approximately 5 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2024-10-29
Completion: 2028-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 392 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Contact Information
Study Contact:
BBOT (BridgeBio Oncology Therapeutics)
650-405-8440
Breaker-101ct.gov@bridgebiooncology.com
Interventions
  • Drug: BBO-10203 — Participants will receive assigned dose of BBO-10203 orally once daily
  • Drug: Trastuzumab — Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
  • Drug: Fulvestrant — Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
  • Drug: Ribociclib — Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
  • Drug: FOLFOX — Patients will receive FOLFOX as infusion every 14 days
Study Locations (40 sites)
City of Hope Comprehensive Cancer Center, Duarte, California 91010 United States
University of California Los Angeles, Los Angeles, California 90095 United States
University of California San Diego Moores Cancer Center, San Diego, California 92093 United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94158 United States
Moffitt Cancer Center, Tampa, Florida 33612 United States
Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana 46202 United States
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Dana-Farber Cancer Insitute, Boston, Massachusetts 02215 United States
St. Lukes Hospital of Kansas City, Kansas City, Missouri 64111 United States
Washington University School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: * Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC) * Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only) * Stable brain metastases * Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC) * Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy * BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i * BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted * BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required Exclusion Criteria: * Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors * Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2) * Patients with untreated and/or non-stable brain metastases Other inclusion/exclusion criteria are specified in the protocol
Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.
NCT04778839
Recruiting
Conditions Advanced Solid Tumors
Phase PHASE1
Enrollment 98
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.

Design

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

Interventions / Regimen

  • Drug: Paclitaxel Micelles for Injection — Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
  • Drug: Paclitaxel injection — Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

Primary Outcomes

  • Safety and tolerability of Paclitaxel Micelles for Injection in dose ascending and dose extension as measured by assessment of maximum tolerated dose (MTD) and dose limiting toxicity (DLT). (2 years)
  • The recommended dose for the phase II study (2 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2021-03-04
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 98 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: First Affiliated Hospital of Zhejiang University
Collaborators: Hangzhou Dihua Biotechnology Co., LTD.
Principal Investigators:
  • jian liu, master (PRINCIPAL_INVESTIGATOR) - The First Affiliated Hospital,ZheJiang Univercity
  • xiaochen zhang, docter (PRINCIPAL_INVESTIGATOR) - The First Affiliated Hospital,ZheJiang Univercity
Contact Information
Study Contact:
jian liu, master
+86-13958054006
lindaliu87@zju.edu.com
xiaochen zhang, docter
+86-13957169922
zhangxiaochen74@163.com
Interventions
  • Drug: Paclitaxel Micelles for Injection — Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
  • Drug: Paclitaxel injection — Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
Study Locations (1 sites)
The First Affiliated Hospital,ZheJiang Univercity, Hanzhou, Zhejiang 310000 China
Eligibility Criteria
Inclusion Criteria: * Participants are required to meet all the criteria below in order to be included in the trial: 1. Confirmed diagnosis of advanced solid tumors by histological or cytological examination, participants have no effective standard anticancer therapy available or is failed to standard anticancer therapy. 2. Male or female patient, aged 18 \~ 70 years. 3. Life expectancy ≥ 3 months. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Participants with at least 1 measurable tumor lesion and/or assessable non-measurable lesion based on RECIST 1.1. 6. No radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy (such as experimental drugs, biological agents, Chinese herbal medicine, etc.), surgical treatment (except diagnostic biopsy), or complete recovery from previous surgery within 4 weeks prior to enrollment, and no surgical operation was planned during the study period. 7. No severe hematopoietic abnormalities(no blood transfusion, no blood products, no granulocyte colony-stimulating factor, platelet stimulating factor, or other hematopoietic growth factors were corrected within 14 days prior to the screening phase laboratory examination):Hb≥90g/L , ANC≥1.5×109/L , PLT≥100×109/L. 8. No serious organic disease of heart, liver or kidney:LVEF≥50% ; ALT(Alanine aminotransferase) or AST(Aspartate transaminase)≤2.5×upper limit of normal(ULN)(for patients with hepatic metastases, ALT or AST≤5 × ULN); TBIL(Total bilirubin)≤1.5×ULN; creatinine≤1.5×ULN and CL≥ 60 mL/min\[The calculation formula was as follows: CCR (140- age)× body weight (kg) /0.818× SCR (μmol/L), and female was calculated as ×0.85\]. 9. The coagulation function is normal:PT、APTT and INR≤1.5×ULN。 10. Participants (including partners) who are willing to follow reliable contraceptive measures during the study and until 3 months after the last dosing(such as intrauterine devices \[IUDs\], birth control pills or condoms).Women of child-bearing age must be negative for serum HCG within 14 days prior to study enrolment and must be non-lactating。 11. Participants with voluntarily signature Informed Consent Form (ICF) before the test, and have a full understanding of the test content, process and possible adverse reactions. 12. Participants with good compliance, were available for follow-up, and volunteered to comply with study regulations. Exclusion Criteria: * Eligible participants must not meet any of the following exclusion criteria: 1. Patients with the toxicity of previous antitumor therapy did not return to grade 1 or below (CTCAE 5.0 grade \>1, excluding toxicity such as alopecia and other toxicity judged by investigators to be of no safety risk). 2. Patients with (including suspected) an allergic history to Paclitaxel, or any of its components, or allergic constitution (excluding mild asymptomatic seasonal allergy). 3. Patients with bleeding tendency or who are receiving thrombolytic or anticoagulant therapy. 4. Patients who had been treated with paclitaxel and were determined by the researchers to be resistant. 5. Patients with active central nervous system metastases,But patients with BMs who have received prior treatment and the metastases were stable can participate in the study. 6. Patients with cerebrovascular accident or transient ischemic attack in the previous 6 months were screened. 7. People with active infection and need anti-infection or antiviral treatment. 8. Patients have suffered from other malignant cancers within 5 years (except for cured basal cell carcinoma and cervical carcinoma in situ). 9. Concomitant diseases, as determined by the investigator, that seriously endangers the safety of subjects or affects their completion of the test(such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, etc). 10. Patients with a clear history of neurological or psychiatric disorders (including epilepsy and dementia). 11. Patients who have used any drugs that is CYP2C8 and/or CYP3A4 inducer or inhibitor Within 30 days before use of the test drug(including ketoconazole and other imidazole antifungal agents, verapamil, diazepam, quinidine, cyclosporine, teniposide, etoposide, vincrine, testosterone, 17-α diethylstilbestrol, retinoic acid, quercetin, etc). 12. Patients who received blood transfusion and transfusion of blood products, such as albumin, within 2 weeks prior to trial. 13. Patients with peripheral neuropathy above grade II. 14. Patients with history of myocardial infarction(within 6 months prior to enrollment) ,severe or unstable angina, coronary or peripheral artery bypass grafting or congestive heart-failure (CHF) at NYHA 3-4 level ;and patients with history of uncontrollable hypertension, arrhythmias considered clinically significant by the investigator, or electrocardiogram (ECG) abnormalities. 15. HIV infection, or active HBV infection (HBsAg and/or HBcAb positive, with peripheral blood HBV DNA ≥1 x 103 IU/ mL), or active HCV infection (HCV antibody positive, HCV RNA≥500 IU/ mL). 16. Alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol,such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine)within 2 weeks before screening, or patients with drug abuse. 17. Patients who participated in other study within the last 1 month. 18. Pregnant or nursing women. 19. Patients who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
NCT03865992
Active, positions filled
Conditions Breast Cancer, Joint Pain
Phase NA
Enrollment 42
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This phase I trial studies how well curcumin works in reducing joint pain in patients who are breast cancer survivors and have joint disease caused by treatment with aromatase inhibitors. Curcumin is an ingredient of turmeric, a plant in the ginger family, which is commonly used in curries and South Asian and Middle Eastern cooking, and may decrease joint pain in patients with arthritis from other conditions (such as osteoarthritis and rheumatoid arthritis).

Design

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

Interventions / Regimen

  • Dietary Supplement: Curcumin — Given capsules for oral administration
  • Other: Placebo — Given capsules for oral administration
  • Other: Nanoemulsion — Given nanoemulsion curcumin PO
  • Other: Quality-of-Life Assessment — Ancillary studies
  • Behavioral: Questionnaire — Ancillary studies

Primary Outcomes

  • Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy (Up to 3 months)
  • Change in Brief Pain Inventory (BPI) pain score (Baseline up to 3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2019-03-04
Completion: 2026-09-08
Eligibility
Age: No restriction
Sex: FEMALE
Volunteers: false
Enrollment: 42 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Lisa D Yee, MD (PRINCIPAL_INVESTIGATOR) - City of Hope Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dietary Supplement: Curcumin — Given capsules for oral administration
  • Other: Placebo — Given capsules for oral administration
  • Other: Nanoemulsion — Given nanoemulsion curcumin PO
  • Other: Quality-of-Life Assessment — Ancillary studies
  • Behavioral: Questionnaire — Ancillary studies
Study Locations (4 sites)
City of Hope Medical Center, Duarte, California 91010 United States
City of Hope Rancho Cucamonga, Rancho Cucamonga, California 91730 United States
City of Hope South Pasadena, South Pasadena, California 91030 United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210 United States
Eligibility Criteria
Inclusion Criteria: * Women with histologically confirmed primary invasive adenocarcinoma of the breast, stages I-IIIA * Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) breast cancer * Completion of definitive surgery with mastectomy or breast conserving therapy * Postmenopausal (no menses \>= 12 months) or on ovarian suppression in order to take AIs * Currently taking an Food and Drug Administration (FDA) approved third-generation aromatase inhibitor (e.g., anastrozole \[Arimidex\], letrozole \[Femara\], or exemestane \[Aromasin\]) for \>= 90 days prior to registration with plans to continue for \>= 90 days after registration * Clinical symptoms of joint pain for at least 3 months prior to study entry that started or increased with AI therapy with Brief Pain Inventory (BPI) Worst Pain score \>= 4 (verbal response to BPI question 3 regarding the worst pain in the past 24 hours as 0 "no pain" to 10 "pain as bad as you can imagine") Exclusion Criteria: * Prior malignancy =\< 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission * History of a bleeding tendency or current use of coumadin or other anticoagulants * Current or previous history of anemia * Current autoimmune, liver, hematopoietic, cardiac, or renal disease * Current viral, bacterial, atypical or fungal infections of any organ system * Concurrent use of immunosuppressant medications * Concurrent use of medications known to inhibit or induce hepatic enzyme CYP 3A4 (e.g. ketoconazole, macrolide antibiotics, barbiturates) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements * Bone fracture or surgery of the affected joints, within 180 days of study entry * Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness =\< 30 days of study entry * Intra-articular steroids =\< 90 days of study entry or oral/intramuscular corticosteroids \< 30 days of entry * Use of analgesics (e.g., opiates, tramadol with the exception of nonsteroidal anti-inflammatory drugs \[NSAIDs\] and acetaminophen) within 14 days prior to registration, or at any time during the 3-month study period * Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids =\< 3 months of study entry or any other supplements that might interact with NEC (e.g. St. John's Wort) * Known sensitivity or allergy to turmeric spices or curry
Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy
NCT00877500
Active, positions filled
Conditions Bilateral Breast Carcinoma, HER2/Neu Neg...
Phase PHASE2
Enrollment 116
Locations 3 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death.

Design

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

Interventions / Regimen

  • Other: Best Practice — Receive standard of care
  • Drug: Ixabepilone — Given IV

Primary Outcomes

  • Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors (Up to 5 years)
  • Significant circulating tumor cells (CTCs) (At 18 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2009-03-30
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 116 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Funda Meric-Bernstam (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: Best Practice — Receive standard of care
  • Drug: Ixabepilone — Given IV
Study Locations (3 sites)
Advocate Christ Medical Center, Oak Lawn, Illinois 60453-2699 United States
Lyndon Baines Johnson General Hospital, Houston, Texas 77026-1967 United States
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Patients with histologic confirmation of invasive HER2/neu-negative breast cancer (immunohistochemistry \[IHC\] 0-1+ or fluorescence in situ hybridization \[FISH\]-negative) that have received complete anthracycline and taxane neoadjuvant systemic therapy and that at the time of surgery are expected to have significant residual disease. Therapy should include at least 4 cycles of an anthracycline-based regimen (adriamycin-cytoxan \[AC\], 5-fluorouracil/adriamycin/intravenous \[IV\] cyclophosphamide \[FAC\], fluorouracil-epirubicin-IV cytoxan \[FEC\]) and 12 weeks of a taxane-based regimen (weekly paclitaxel, every 3-week docetaxel). * Patients who did not complete therapy due to disease progression are eligible. * Patients with bilateral breast cancers are eligible. * Patients should have a Karnofsky performance scale of \>= 70%. * Peripheral granulocyte count of \>= 1500/mm\^3. * Platelet count \>= 100000 mm\^3. * Bilirubin within normal laboratory values. * Alkaline phosphatase may be up to 1.5 x upper limit of normal (ULN) of the institution. * Transaminases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) may be up to 1.5 x upper limit of normal (ULN) of the institution. * Creatinine levels within normal range. * Negative serum pregnancy test for a woman of childbearing potential. * Women of childbearing potential (WOCP) must use a reliable and appropriate contraceptive method during the study and 6 months after chemotherapy is completed. Women of childbearing potential (WOCBP) are women who are not menopausal for 12 months or had no previous surgical sterilization. * Patients must agree to have study tissue collections and blood sample collections. * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy. * Patients should have their surgical tissues evaluated for residual cancer burden (RCB) and be used for correlative studies. * Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. * All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP will be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The principal investigator (PI) will immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study. Exclusion Criteria: * Patients whose tumors express HER2 protein or have HER2/neu gene amplification. * Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer. * Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper gastrointestinal \[GI\] tract ulceration). * Patients with a pre-existing peripheral neuropathy \> grade 1. * Evidence of distant metastases.
Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
NCT05710328
Active, positions filled
Conditions Anatomic Stage II Breast Cancer AJCC v8,...
Phase PHASE2
Enrollment 235
Locations 102 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

Design

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

Interventions / Regimen

  • Drug: Chemotherapy — Receive standard of care chemotherapy
  • Procedure: Computed Tomography — Undergo PET/CT
  • Other: Fludeoxyglucose F-18 — Given IV
  • Procedure: Positron Emission Tomography — Undergo PET/CT
  • Procedure: Surgical Procedure — Undergo standard of care surgery

Primary Outcomes

  • Negative predictive value of neoadjuvant interim (ni) fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) for pathologic complete response (pCR) (Up to 5 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2023-05-10
Completion: 2029-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 235 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: ECOG-ACRIN Cancer Research Group
Principal Investigators:
  • Heather Jacene (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: Chemotherapy — Receive standard of care chemotherapy
  • Procedure: Computed Tomography — Undergo PET/CT
  • Other: Fludeoxyglucose F-18 — Given IV
  • Procedure: Positron Emission Tomography — Undergo PET/CT
  • Procedure: Surgical Procedure — Undergo standard of care surgery
Study Locations (102 sites)
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233 United States
Cancer Center at Saint Joseph's, Phoenix, Arizona 85004 United States
Los Angeles General Medical Center, Los Angeles, California 90033 United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California 90033 United States
Saint John's Cancer Institute, Santa Monica, California 90404 United States
Sibley Memorial Hospital, Washington D.C., District of Columbia 20016 United States
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980 United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii 96813 United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii 96813 United States
Queen's Medical Center, Honolulu, Hawaii 96813 United States
Eligibility Criteria
Inclusion Criteria: * Patients (all genders) must be \>= 18 years of age. * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines that has been determined by local testing. * Patient must have known (either positive or negative) hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) status by local testing, per ASCO/CAP guidelines. Patients with either hormone receptor-positive or hormone receptor- negative HER2-positive breast cancer are eligible. * Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria. * Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-4) * Patients with nodal involvement (cN1-3) are eligible if T2-4 * Patients with clinical T4d are not eligible * Patients with bilateral invasive breast cancers are eligible if both cancers are HER2-positive and at least one meets all protocol eligibility criteria and neither cancer renders the patient ineligible. * Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive and at least one tumor focus meets all eligibility criteria. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing. * Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars) based regimen. * 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 this imaging intervention are eligible for this trial. * Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. * Patient must be participating in the trial at an institution which has agreed to perform the imaging research studies, completed the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Center Group (ECOG-ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval. * For patients who completed the baseline (T0) FDG-PET/CT PRIOR to registration, neoadjuvant pertuzumab-based regimen must start after study registration and within 21 days after the T0 scan. * Patients must not have used colony stimulating growth factors within 14 days prior to completing a T0 scan done prior to registration. Exclusion Criteria: * Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy. * 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 teratogenic effects of FDG in addition to the radiation exposure during PET/CT. All patients of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy. * NOTE: A pregnancy test within 7 days prior to the T0 scan is also required but will only need to be done if a) the T0 scan is completed after study registration and b) if the pregnancy test done prior to registration is completed outside of the 7-day window. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Patient must not have any contraindication to FDG-PET/CT imaging which includes routine glucose values \> 200 mg/dL and severe claustrophobia.
SABER Study for Selected Early Stage Breast Cancer
NCT04360330
Recruiting
Conditions Breast Cancer, Early-stage Breast Cancer
Phase NA
Enrollment 18
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-29
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.

Design

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

Interventions / Regimen

  • Radiation: Stereotactic Ablative Breast Radiotherapy — Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy) * Dose Level III: 45 Gy (5 fractions of 9 Gy) * Dose Level IV: 50 Gy (5 fractions of 10 Gy)

Primary Outcomes

  • Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER (Up to 13 Weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2020-08-05
Completion: 2028-05
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: false
Enrollment: 18 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Miami
Principal Investigators:
  • Cristiane Takita, MD, MBA (PRINCIPAL_INVESTIGATOR) - University of Miami
Contact Information
Study Contact:
Zuzel Rodriguez
305-243-0124
z.rodriguez1@med.miami.edu
Interventions
  • Radiation: Stereotactic Ablative Breast Radiotherapy — Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy) * Dose Level III: 45 Gy (5 fractions of 9 Gy) * Dose Level IV: 50 Gy (5 fractions of 10 Gy)
Study Locations (1 sites)
University of Miami, Miami, Florida 33136 United States
Eligibility Criteria
Inclusion Criteria: 1. Female, ≥ 50 years of age. 2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment 3. Histologically confirmed invasive breast cancer. 4. Clinical stage T1N0M0. 5. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative. 6. Unifocal breast cancer. 7. Eastern Cooperative Oncology Group (ECOG) 0, 1. 8. Ability to undergo MRI. 9. Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 10. Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s). Exclusion Criteria: 1. Patients without histologically confirmed invasive breast cancer. 2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment. 3. Patients with metastatic disease. 4. ECOG 2, 3, 4. 5. Patients that are unable to undergo MRI. 6. Prior history of radiation to the chest. 7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis). 8. Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment. 9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer. 10. Patients unable to consent, who are pregnant or nursing, or are prisoners.