Clinical Trial Matcher

CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer

NCT04176848

Active, positions filled

Conditions Breast Cancer

Phase PHASE2

Enrollment 15

Locations 5 sites

Compensation Phase 2: Typically $500-$2,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The purpose of this study is to find out the effect that CFI-400945 and durvalumab have on breast cancer.

Design

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

Interventions / Regimen

Drug: CFI-400945 — CFI-400945 32 mg: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: orally once daily
Drug: Durvalumab — Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)

Primary Outcomes

Objective Response Rate (24 months)

Study Information

Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2020-08-10
Completion: 2026-12-31

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 15 (ACTUAL)

Sponsor & Investigators

Lead Sponsor: Canadian Cancer Trials Group
Collaborators: AstraZeneca, University Health Network, Toronto

Principal Investigators:

David Cescon (STUDY_CHAIR) - University Health Network, PMH, Toronto ON
Andrew Robinson (STUDY_CHAIR) - Cancer Centre of Southeastern Ontario at Kingston, ON

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Drug: CFI-400945 — CFI-400945 32 mg: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: orally once daily
Drug: Durvalumab — Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)

Study Locations (5 sites)

BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia V1Y 5L3 Canada

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario L8V 5C2 Canada

Kingston Health Sciences Centre, Kingston, Ontario K7L 2V7 Canada

Ottawa Hospital Research Institute, Ottawa, Ontario K1H 8L6 Canada

University Health Network, Toronto, Ontario M5G 2M9 Canada

Eligibility Criteria

Inclusion Criteria: * Patients must have histologically and/or cytologically confirmed diagnosis of breast cancer, that is advanced/metastatic or unresectable, for which no curative therapy exists, and be negative for ER, PR and HER2 by ASCO/CAP criteria on the most recent sample. Patients with tumour with either low (\< 10%) ER expression who are PR and HER2 negative, or ER and HER2 negative but with low PR (\< 10%) may be enrolled after discussion and confirmation with CCTG * Only female patients will be enrolled * All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block. * Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 21 days prior to enrollment (within 28 days if negative). * All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows: * Chest x-ray ≥ 20 mm * CT scan (with slice thickness of 5 mm) ≥ 10 mm -\> longest diameter * Physical exam (using calipers) ≥ 10 mm * Lymph nodes by CT scan ≥ 15 mm -\> measured in short axis * Patients must be ≥ 18 years of age * Patients must have an ECOG performance status of 0 or 1 * Patients must have a life expectancy of 3 months or longer * Laboratory Requirements (must be done within 7 days prior to enrollment) Absolute neutrophils ≥ 1.5 x 10\^9/L Platelets ≥ 100 x 10\^9/L Bilirubin ≤ 1.5 x ULN (upper limit of normal) AST and ALT ≤ 2.5 x ULN, ≤ 4.0 x ULN if patient has liver metastases Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min * Patients must be able to swallow oral medications and have no known gastrointestinal disorders that may interfere with absorption (such as malabsorption). * Patients must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated). Select patients that have not received both anthracycline and taxane therapy may be considered eligible after discussion with CCTG. There is no limit to the number of prior chemotherapy regimens. * Patients may have received other therapies including endocrine therapy and/or targeted therapies (including CDK4/6 inhibitors and PARP inhibitors). * Patients may not have received prior immunotherapies of any kind, nor any agent targeting PLK4. * Patients must have recovered (to at least grade 0 or 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows: Longest of one of the following: * Two weeks, * 5 half-lives for investigational agents, * Standard cycle length of standard therapies. * Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted. * Previous surgery is permitted provided that a minimum of 21 days (3 weeks) have elapsed between any major surgery and date of enrollment, and that wound healing has occurred. * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial * In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment * Women of childbearing potential must have agreed to use a highly effective contraceptive method. * Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected * Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab Exclusion Criteria: * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \> 2 years and which do not require ongoing treatment. * Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to: * History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements. * Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy). * Active peptic ulcer disease or gastritis. * Known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function. * Patients with diabetes mellitus are eligible but must be clinically stable on therapy (if applicable) and investigator and patient should be aware of the potential risk of immune mediated pancreatic toxicity and B cell destruction. * Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components. * Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%. * Patients may not receive concurrent treatment with other anti-cancer therapy (other than bone- targeted therapy, if already taking and stable) or investigational agents while on protocol therapy. * Patients who have received growth factors within 28 days prior to initiation of dosing of CFI- 400945 or who will require treatment with growth factors throughout the duration of the trial. * Pregnant or breastfeeding women. * Patients being treated with drugs listed in Appendix VI Table 1 are excluded. Patients being treated with drugs listed in Appendix VI Table 2 may be enrolled, but should be monitored carefully for toxicities resulting from potential interactions between CFI-400945 and these drugs. In addition, patients must avoid consumption of the fruit or juice of Seville oranges (e.g. marmalade), grapefruit, pomelos and star fruit from 7 days before the first dose of study drug and during the entire study due to potential CYP3A4 interaction with the study drug. Regular orange juice is allowed. * Patients with history of central nervous system metastases or spinal cord compression unless they have received definitive treatment, are clinically stable and do not require corticosteroids. * Patients with any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting. * Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polya

Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique

NCT04918082

Active, positions filled

Conditions Breast Neoplasms, Quality of Life, Survi...

Phase Not Applicable

Enrollment 133

Locations 1 sites

Compensation Compensation varies

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

Cancer and its treatments can be factors that alter the quality of life of patients. The induced alteration of the quality of life can influence compliance and impact survival. Considering the after-effects of the treatment, carrying out such a survey will provide for the first time precise information on the main determinants of the quality of life as well as on the care pathway of patients with invasive breast cancer in the Martinique region.

Design

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

Interventions / Regimen

Other: Quality of life questionnaires — Patients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules.

Primary Outcomes

Assessment of global disorders in patients with breast cancer (12 months after diagnosis)
Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients (12 months after diagnosis)
Assessment of global disorders in patients with breast cancer (36 months after diagnosis)
Assessment of disorders specific to breast cancer patients (36 months after diagnosis)

Study Information

Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2020-10-28
Completion: 2027-03-31

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 133 (ACTUAL)

Sponsor & Investigators

Lead Sponsor: University Hospital Center of Martinique

Principal Investigators:

Clarisse JOACHIM-CONTARET (PRINCIPAL_INVESTIGATOR) - CHU Martinique

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Other: Quality of life questionnaires — Patients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules.

Study Locations (1 sites)

CHU Martinique, Fort-de-France, 97261 Martinique

Eligibility Criteria

Inclusion Criteria: * Patient over 18 years of age residing in Martinique with invasive breast cancer diagnosed from 2020 (single tumor at diagnosis) * Patients who have read the information note and have indicated that they do not wish to participate in the study * Patient with social security coverage. Exclusion Criteria: * Refusal to participate * Patient with insitu breast cancer * Patient with a second cancer * Patient with cancer within 5 years prior to inclusion * Patient who could not answer quality of life questionnaires * Patient not fluent in French * Person under legal protection (safeguard of justice, guardianship, curators , etc.).

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

NCT03821935

Active, positions filled

Conditions Advanced Solid Tumors Cancer

Phase PHASE1

Enrollment 364

Locations 64 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

Design

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

Interventions / Regimen

Drug: Livmoniplimab — Liquid for intravenous infusion.
Drug: Budigalimab — Lyophilized powder for solution for intravenous infusion.

Primary Outcomes

Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy (Up to 28 days after the first dose of Livmoniplimab monotherapy)
Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy (Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy)
Dose Expansion: Objective Response Rate (ORR) (Up to approximately 6 months after the first dose date of last participant in Dose Expansion)

Study Information

Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2019-02-21
Completion: 2027-06

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 364 (ACTUAL)

Sponsor & Investigators

Lead Sponsor: AbbVie

Principal Investigators:

ABBVIE INC. (STUDY_DIRECTOR) - AbbVie

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Drug: Livmoniplimab — Liquid for intravenous infusion.
Drug: Budigalimab — Lyophilized powder for solution for intravenous infusion.

Study Locations (64 sites)

Highlands Oncology Group, PA /ID# 218942, Springdale, Arkansas 72762 United States

City of Hope National Medical Center /ID# 265620, Duarte, California 91010 United States

City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785, Irvine, California 92618 United States

Yale University School of Medicine /ID# 208356, New Haven, Connecticut 06510 United States

AdventHealth Celebration /ID# 224860, Celebration, Florida 34747-4970 United States

Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953, Orlando, Florida 32804 United States

Indiana Univ School Medicine /ID# 208384, Indianapolis, Indiana 46202 United States

Community Health Network, Inc. /ID# 257032, Indianapolis, Indiana 46250-2042 United States

Univ Michigan Med Ctr /ID# 221129, Ann Arbor, Michigan 48109 United States

Washington University-School of Medicine /ID# 259684, St Louis, Missouri 63110 United States

Eligibility Criteria

Inclusion Criteria: * For Dose Escalation only: Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition. Additionally, participants who have been offered standard therapies and refused, or who are considered ineligible for standard therapies, may be eligible for this study on a case-by-case basis, after discussion with and agreement from the sponsor. Participants with pancreatic adenocarcinoma, urothelial cancer (UC), hepatocellular carcinoma (HCC), or head and neck squamous cell carcinoma (HNSCC) who are being considered for the dose escalation cohorts must also meet the histology specific eligibility criteria described below for dose expansion. * For Dose Expansion only participants must meet criteria specific to the type of cancer: * Pancreatic adenocarcinoma and have disease progression during or after 1 systemic therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX \[or another regimen including both 5-fluorouracil and oxaliplatin\], capecitabine monotherapy or in combination with other agents) administered in the adjuvant, locally advanced, or metastatic setting. If the therapy was used in an adjuvant setting, disease progression must have occurred within 6 months of completing adjuvant therapy. * UC of the bladder and urinary tract and must have progressed following treatment with: * Cohort 4: A platinum-based regimen (administered in any line of therapy) and a programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy). * Cohort 11: One or more prior line of therapy in the locally advanced or metastatic setting. Participant must have experienced radiographic progression or relapse during or after a CPI (anti-PD1 or anti-PD-L1) for locally advanced or metastatic disease. * HCC and must have disease progression during or after 1 prior line of systemic therapy. * HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy). * Microsatellite stable colorectal cancer (MSS-CRC) \[unselected\] participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (as determined by polymerase chain reaction (PCR)/Next-Generation sequencing (NGS) or immunohistochemistry (IHC), respectively) who have received 1-2 prior chemotherapy regimens. * Non-small cell lung cancer (NSCLC) relapsed/refractory (R/R): Participants with histologically or cytologically confirmed advanced or metastatic NSCLC who have received 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody, administered either concurrently or sequentially in the metastatic setting. * MSS-CRC (CMS4 enriched): Participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma who have received prior fluorouracil-based combination chemotherapy regimens including oxaliplatin and irinotecan (with or without VEGF and/or EGFR targeted agents) and with a CMS4 subtype as determined by NGS of tumor biopsies. Archival tissue must be submitted for assessment of CMS4 subtype status during prescreening. Participants must have progressed on or refused available standard of care therapies. Additionally, participant who are considered not appropriate or ineligible for available standard of care therapies per investigator assessment will be eligible for this study. * Ovarian granulosa (OG) cell tumor: Participants with histologically confirmed advanced nonresectable or metastatic adult granulosa cell tumor of the ovary that is not amenable to curative intent surgery or radiation. Additionally, there is documentation of radiological evidence of relapse after at least 1 line of systemic chemotherapy. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Participant has adequate bone marrow, renal, hepatic, and coagulation function. * Must have a viral status consistent with the requirements described in the protocol specific to type of cancer and stage of study (Dose Escalation or Dose Expansion). Exclusion Criteria: * For Dose Expansion only: * Participants with HCC, pancreatic adenocarcinoma, or MSS-CRC having prior exposure to a prior PD-1/PD-L1 antagonist in any line of therapy. * Participants (except for participants with urothelial cancer or HNSCC) who have had prior exposure to immunotherapies as listed in the protocol. * Has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives or 28 days (whichever is shorter), prior to the first dose of the study drug. * Participant has unresolved AEs \> Grade 1 from prior anticancer therapy except for alopecia. * Has a history of primary immunodeficiency, bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis. * Has a known uncontrolled metastases to the central nervous system (with certain exceptions). * Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study drug. * Has clinically significant uncontrolled condition(s). * History of inflammatory bowel disease, interstitial lung disease or pneumonitis, myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms (DRESS). * Live vaccine administration \<= 28 days prior to the first dose of study drug.

Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients

NCT06962163

Recruiting

Conditions Metastatic Breast Cancer

Phase NA

Enrollment 12

Locations 1 sites

Compensation Compensation typically provided

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Unfortunately, patients with TNBC have a lower survival rate, often less than five years after diagnosis. This highlights the urgent need for better treatments for TNBC. One of the main challenges in treating TNBC is that it lacks certain receptors that other breast cancers have. These receptors are usually targeted by specific therapies, making TNBC harder to treat with targeted approaches. Currently, a type of imaging called \[18F\]FDG PET/CT is the most accurate method for detecting breast cancer and its spread. However, with the rise of personalized medicine, there is a growing interest in molecular targeted approaches. These methods aim to provide highly specific diagnostics and treatments based on the unique characteristics of each patient's cancer. One promising target for these new approaches is a receptor called CXCR4. CXCR4 is found on the surface of many cells and is involved in various processes in the body. It is often overexpressed in different types of cancer, including breast cancer. Research has shown that CXCR4 levels are higher in metastatic sites (where cancer has spread) compared to primary tumors. CXCR4 is not only present in cancer cells but also in immune cells within the tumor environment. In invasive breast cancer, CXCR4 plays a crucial role in tumor migration, invasiveness, metastasis, and proliferation. A clinical study evaluated 18 breast cancer patients using a new imaging method called \[68Ga\]Ga-PentixaFor PET/CT or PET/MR. They found that this method showed higher uptake in breast cancer cases with poorer prognosis compared to the traditional \[18F\]FDG PET/CT. Higher CXCR4 expression is particularly seen in TNBC compared to other breast cancer subtypes. The goal of the study is to assess how \[68Ga\]Ga-PentixaFor is distributed in the body using PET/CT imaging. This will help demonstrate the potential of CXCR4 as a promising target for new treatments. If successful, \[68Ga\]Ga-PentixaFor PET/CT could become a valuable tool for identifying patients who might benefit from treatments using \[177Lu\]/\[90Y\] PentixaTher.

Design

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

Interventions / Regimen

Diagnostic Test: [68Ga]Ga-PentixaFor PET/CT — \[68Ga\]Ga-PentixaFor PET-CT is performed after patient inclusion. The patient is treated as per standard of care until disease progression. Then another \[68Ga\]Ga-PentixaFor PET-CT is performed.

Primary Outcomes

To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion (1 day)

Study Information

Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-12-05
Completion: 2030-06

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Institut Cancerologie de l'Ouest

Principal Investigators:

CAROLINE ROUSSEAU, MD, PhD (PRINCIPAL_INVESTIGATOR) - Institut de Cancérologie de l'Ouest (ICO)

Contact Information

Study Contact:

CAROLINE ROUSSEAU, MD, PhD

+33 2 40 67 99 31

Caroline.Rousseau@ico.unicancer.fr

NADIA ALLAM, PhD

+33 2 40 67 98 26

nadia.allam@ico.unicancer.fr

Interventions

Diagnostic Test: [68Ga]Ga-PentixaFor PET/CT — \[68Ga\]Ga-PentixaFor PET-CT is performed after patient inclusion. The patient is treated as per standard of care until disease progression. Then another \[68Ga\]Ga-PentixaFor PET-CT is performed.

Study Locations (1 sites)

Institut de cancerologie de l'Ouest, Saint-Herblain, 44805 France

Eligibility Criteria

Inclusion Criteria: 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. 2. Female or male, Age ≥ 18 years at time of study entry. 3. Primitive triple negative breast cancer proven histologically, defined according to the following criteria: * Estrogen receptors \<10%. * And progesterone receptors \<10%. * And HER2 not amplified or not overexpressed. 4. Recurrence metastatic Breast Cancer or De Novo metastatic Breast Cancer documented by \[18F\]FDG PET/CT ± conventional imaging with at least one measurable metastasis according to PERCIST and/or RECIST. 5. ECOG performance status \< 2. 6. Negative serum/urine pregnancy test prior to \[68Ga\]Ga-PentixaFor administration for female patient of childbearing potential\*. 7. Consent to use a contraception method for at least 3 months after each administration of \[68Ga\]Ga-PentixaFor (as defined in Appendix 7 and according to local guidelines). 8. Adequate Organ function confirmed by laboratory tests results allowing for safe administration of \[68Ga\]Ga- PentixaFor: Hematologic function: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109 /L, platelet count of ≥ 100 x 109 /L, and hemoglobin of ≥ 9 g/dL). Hepatic function: AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases). 9. Renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min/1.73m², as calculated using the CKD-EPI or MDRD equation.Life expectancy at least 3 months. 10. Patient has valid health insurance. 11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Note: a female participant of childbearing potential is a woman who is not permanently sterilized or not postmenopausal (postmenopausal is defined as 12 months with no menses without an alternative medical cause). Exclusion Criteria: 1. History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma. 2. Impossibility to hold lying motionless at least 1 hour, or known claustrophobia. 3. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator. 4. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 5. Pregnant, likely to be pregnant or breastfeeding woman. 6. Blood glucose \> 12mmol/L. 7. Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m². 8. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product. 9. Body weight of less than 48 kg. 10. Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian. 11. Disorder precluding understanding of trial information or informed consent.

Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control

NCT03351348

Active, positions filled

Conditions Breast Cancer

Phase PHASE3

Enrollment 165

Locations 7 sites

Compensation Phase 3: Typically $200-$1,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

Drug: Bupivacaine — The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
Behavioral: patient-reported pain scores — Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).
Other: saline — The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Primary Outcomes

number of patients that have moderate to severe pain (up to 24 hours)

Study Information

Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2017-11-16
Completion: 2027-11

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 165 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Principal Investigators:

Laurie Kirstein, MD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Drug: Bupivacaine — The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
Behavioral: patient-reported pain scores — Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).
Other: saline — The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Study Locations (7 sites)

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only), Basking Ridge, New Jersey 07920 United States

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey 07748 United States

Memorial Sloan Kettering Bergen (Consent and follow-up only), Montvale, New Jersey 07645 United States

Memorial Sloan Kettering Commack (Consent and follow-up only), Commack, New York 11725 United States

Memorial Sloan Kettering Westchester (Consent and follow-up only), East White Plains, New York 10604 United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States

Memorial Sloan Kettering Nassau (Consent and follow-up only), Uniondale, New York 11553 United States

Eligibility Criteria

Inclusion Criteria: * Patients ≥ 18 years of age * Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection * Patients scheduled for surgery at the JRSC or MSK Monmouth * Previously enrolled patients \> 6 months from contralateral mastectomy Exclusion Criteria: * Patients who are non-English speaking * Patients having any immediate breast reconstructive procedure * Patients are having bilateral mastectomy * Patients who report a baseline pain score \> 3, unrelated to a breast procedure * Patients who take long acting opioid medication use * Patients will be excluded if they are having their mastectomy performed with tumescence * Patients weighing \< 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose * Patients within 6 months of previous enrollment for surgery for contralateral mastectomy

Social Risk Factors and Discrimination in Cancer Survivorship

NCT05301114

Active, positions filled

Conditions Social Determinants of Health, Breast Ca...

Phase NA

Enrollment 1116

Locations 1 sites

Compensation Compensation typically provided

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. This will be completed through three primary aims: 1) To ascertain workflow and map community resources needed to facilitate social risk factor screening and referral for breast and prostate cancer survivors in Washington, District of Columbia. 2) To determine impact of Community Health Worker (CHW) support on Black breast and prostate cancer survivor health and wellbeing as measured through quality of life (QOL) and social connection. 3) To determine impact of anti-racism training for staff and clinicians at three cancer centers on patient-reported discrimination.

Design

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

Interventions / Regimen

Behavioral: Community Health Worker support — Participant will receive weekly or monthly support (via phone or in person) from a community health worker. The community health worker will be responsible for continuously assessing the patient's social needs, providing referrals to community based organizations, and assisting with the patient's non-medical needs as they progress through survivorship (e.g. social support, referrals, etc). Individuals who identify no risk factor will receive monthly phone calls, while individuals who identify 1-3 risk factors will receive monthly home visits with interim phone calls for 6 months. Those who identify 4 or more risk factors or have intensive needs such as behavioral health will receive the same services as the medium risk group and will also be connected with the social work teams within each institution.

Primary Outcomes

Patient Self-Efficacy (6 months)
Health-related quality of life (QOL) (6 months)
Social connectedness (6 months)
Acceptability of the CHW intervention (12 months)
Appropriateness of the CHW intervention (12 months)
Feasibility of the CHW intervention (12 months)
Sustainability Assessment (12 months)

Study Information

Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2022-05-05
Completion: 2026-09-30

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1116 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Medstar Health Research Institute
Collaborators: George Washington University, Howard University, Georgetown University

Principal Investigators:

Hannah Arem, PhD (PRINCIPAL_INVESTIGATOR) - Medstar Health Research Institute
Mandi Pratt-Chapman, PhD (PRINCIPAL_INVESTIGATOR) - George Washington University

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Behavioral: Community Health Worker support — Participant will receive weekly or monthly support (via phone or in person) from a community health worker. The community health worker will be responsible for continuously assessing the patient's social needs, providing referrals to community based organizations, and assisting with the patient's non-medical needs as they progress through survivorship (e.g. social support, referrals, etc). Individuals who identify no risk factor will receive monthly phone calls, while individuals who identify 1-3 risk factors will receive monthly home visits with interim phone calls for 6 months. Those who identify 4 or more risk factors or have intensive needs such as behavioral health will receive the same services as the medium risk group and will also be connected with the social work teams within each institution.

Study Locations (1 sites)

MedStar Washington Hospital Center, Washington D.C., District of Columbia 20010 United States

Eligibility Criteria

Inclusion Criteria: * Diagnosis of stage I-III breast or prostate cancer and completed curative treatment (surgery, radiation, chemotherapy) or finalized treatment plan (e.g. watch and wait); OR Stage IV breast or prostate cancer approximately 6 months from diagnosis * Black or African American race

Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations

NCT02917421

Active, positions filled

Conditions Breast Cancer

Phase PHASE1, PHASE2

Enrollment 88

Locations 3 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.

Design

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

Interventions / Regimen

Radiation: Radiation — (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

Primary Outcomes

Acute Toxicity Will be Measured by Evaluating the Number of Patients Who Experience Grade II-III Dermatitis Within 60 Days of Radiation Therapy. (60 days from start of radiation therapy.)

Study Information

Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2016-12-19
Completion: 2026-12-31

Eligibility

Age: 19 Years
Sex: FEMALE
Volunteers: false
Enrollment: 88 (ACTUAL)

Sponsor & Investigators

Lead Sponsor: Weill Medical College of Cornell University

Principal Investigators:

Silvia Formenti, M.D. (PRINCIPAL_INVESTIGATOR) - Weill Cornell Medicine - New York Presbyterian Hospital

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Radiation: Radiation — (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

Study Locations (3 sites)

New York Presbyterian Hospital - Queens, New York, New York 10065 United States

Weill Cornell Medical College, New York, New York 10065 United States

Brooklyn Methodist Hospital - NewYork Presbyterian, New York, New York 11215 United States

Eligibility Criteria

The study will also include patients who because of COVID had undergone up to 3 months neoadjuvant hormonal therapy before surgery for clinical T1/T2 BC. Inclusion Criteria: * Age older than 18 * Pre- or post-menopausal women with Stage I-III breast cancer * Status post neoadjuvant systemic therapy * Status post-chemotherapy breast surgery * Original biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm (patients with focally positive margin are not excluded). * Status post segmental mastectomy or mastectomy, with either negative sentinel node biopsy and/or axillary node dissection (at least 6 nodes removed). * Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast and/or nodal area * Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy * Pregnant or lactating women * Concurrent chemotherapy, with the exception of anti HER2neu therapies * Inadequate axillary dissection in a setting of positive sentinel node * Patients with more than 5 nodes involved at axillary dissection will be excluded from this study since they will be eligible to receive radiotherapy to level I and II axilla.

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF

NCT03604315

Recruiting

Conditions Breast Carcinoma, Fallopian Tube Carcino...

Phase PHASE1

Enrollment 300

Locations 1 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.

Design

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

Interventions / Regimen

Procedure: Computed Tomography — Undergo FDG PET/CT
Procedure: Computed Tomography — Undergo \[18F\]FTT PET/CT
Radiation: Fludeoxyglucose F-18 — Given IV
Radiation: Fluorine F 18 Fluorthanatrace — Given IV
Procedure: Positron Emission Tomography — Undergo FDG PET/CT
Procedure: Positron Emission Tomography — Undergo \[18F\]FTT PET/CT

Primary Outcomes

Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography (Up to 4 years)

Study Information

Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2018-12-18
Completion: 2027-06-30

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 300 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

Principal Investigators:

Lilie L Lin (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center

Contact Information

Study Contact:

Lilie Lin

713-563-2300

lllin@mdanderson.org

Interventions

Procedure: Computed Tomography — Undergo FDG PET/CT
Procedure: Computed Tomography — Undergo \[18F\]FTT PET/CT
Radiation: Fludeoxyglucose F-18 — Given IV
Radiation: Fluorine F 18 Fluorthanatrace — Given IV
Procedure: Positron Emission Tomography — Undergo FDG PET/CT

Study Locations (1 sites)

M D Anderson Cancer Center, Houston, Texas 77030 United States

Eligibility Criteria

Inclusion Criteria: * History of known or suspected solid tumor. * At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography \[CT\], magnetic resonance imaging \[MRI\], ultrasound, fludeoxyglucose \[FDG\] PET/CT). Exclusion Criteria: * Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential \< 2 weeks prior to screening as standard of care. * Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. * Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)

NCT05374915

Active, positions filled

Conditions Cutaneous Breast Cancer

Phase PHASE2

Enrollment 15

Locations 2 sites

Compensation Phase 2: Typically $500-$2,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This is an open-label, single cohort study to confirm dose, assessments and timing of response, to support future studies. The primary objective of the trial is to evaluate cutaneous tumor response within total target treatment field to REM-001 therapy assessed using standardized digital photography

Design

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

Interventions / Regimen

Combination Product: REM-001 photodynamic therapy — Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001

Primary Outcomes

Best Overall Objective Response Rate (bORR) (Up to week 24)

Study Information

Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2024-02-12
Completion: 2025-12-31

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Kintara Therapeutics, Inc.

Principal Investigators:

Alina Markova, MD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Combination Product: REM-001 photodynamic therapy — Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001

Study Locations (2 sites)

Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States

Montefiore Einstein Center for Cancer Care, The Bronx, New York 10467 United States

Eligibility Criteria

Inclusion Criteria: * Adult participants 18 years of age or greater. * Participants able and willing to sign informed consent. * Histopathologically confirmed breast cancer metastasis to the skin. * Cutaneous metastasis not suitable for surgical resection. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Symptomatic lesions (including discomfort, pain, discharge, ulceration). * Cutaneous, subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to PDT: * Lesion(s) \> 10 mm and \< 60 mm in longest dimension. * Lesion(s) exhibit at least one of the following symptoms: ulcerated, bleeding, discharging, itchy, painful. * Judged by investigator as eligible for PDT. * Participants are radiotherapy refractory (have received a radiation dose of 60 gray (Gy) or greater to the ipsilateral thorax) or are not otherwise amenable to radiotherapy. * Disease progression on at least 2 courses of systemic therapy: * HR positive/HER2 negative participants: should be refractory to endocrine therapy (at least 2 different regimens including at least one CDK4/6 inhibitor). Maintenance endocrine therapy at the clinician's discretion is allowed. * HER2 positive participants should have had disease progression on at least 2 different regimens of HER2 targeted therapies. Maintenance therapy on trastuzumab (HERCEPTIN®) is allowed. * If participants are on systemic therapy at enrollment, they must meet the following: * Participants must have undergone a minimum of two cycles of systemic therapy prior to enrollment. * The systemic therapy must be one from the Treatment of Physician's Choice (TPC) list, as follows: : eribulin mesylate (Halaven®); capecitabine (Xeloda®); Gemcitabine (Gemzar®); a taxane \[either docetaxel (Taxotere®), nab-paclitaxel (Abraxane®), or paclitaxel (Taxol®)\]; vinorelbine (Navelbine®); an antibody-drug conjugate \[either sacituzumab-govitecan (Trodelvy®), trastuzumab-deruxtecan (Enhertu®), or ado-trastuzumab emtansine (KADCYLA®)\]; pembrolizumab (Keytruda®); or carboplatin (Paraplatin®). * Patients who are not on any chemotherapy will also be eligible. * At the time of enrolment, participants should have no known plans to change or modify their TPC regimen while receiving study treatment. Note: TPC regimen may be changed or modified after treatment with REM-001 therapy, but this should be done in consultation with the Sponsor Medical Monitor. * Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using the CKD-EPI Creatinine Equation without race. * Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, hemoglobin ≥ 8.5 g/dL and platelet count ≥ 100 × 10\^9/L; INR \< 1.5. * Adequate liver function as evidenced by bilirubin ≤ 2.0 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (in the case of liver metastases ≤ 5 × ULN) \[Participants with known Gilbert's Syndrome who have serum bilirubin \< 1.5 x ULN (NCI CTCAE v5.0 Gr 2) may be enrolled\]. * QTCF \< 470msec on baseline ECG * Woman of childbearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to registration and must agree to practice adequate contraception * Male patients must be sterile or willing to use an approved method of contraception from the time of treatment with REM-001 until 90 days after study drug treatment. Exclusion Criteria: * Participants who have received local cryotherapy, radiotherapy, intra-lesional chemotherapy, systemic or topical PDT, or surgery to study lesion fields within the past 12 weeks. * Participants with progressive brain or subdural metastases, or leptomeningeal disease. * Participants with previously treated brain or subdural metastases may participate provided: * Previously treated brain metastases are stable and without evidence of progression, as determined by contrast-enhanced CT or MRI brain scan, for at least 4 weeks prior to the first dose of study treatment. * There is no evidence of new brain metastases * They have completed local therapy and discontinued the use of corticosteroids for this indication for at least 4 weeks prior to first dose of study treatment. * Any neurologic symptoms attributed to brain metastases must have been stable for at least 4 weeks prior to study enrollment * History of allergic or hypersensitivity reactions to light, egg proteins or egg yolk; history of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum. * Known disorder of lipoprotein metabolism or clearance (cholesterol\> 400 mg/dl, and/or triglycerides \> 500 mg/dl). * Participants who have received investigational agents within the past 4 weeks or within 4 half-lives of the investigational agent (whichever is shorter) before the first study drug dose. * Participants with inflammatory breast cancer. * Known human immunodeficiency virus (HIV) infection with detectable virus titer. * Active or chronic hepatitis B or C infection. * Active or ongoing infection requiring systemic treatment. * Participants who have undergone major surgery within 4 weeks of study treatment, or have planned surgery within 4 weeks of anticipated initiation of treatment with REM-001 therapy. * Participants with otherwise unexplained weight loss (\> 10% body weight) in the last 30 days prior to Screening. * History of other malignancy treated with curative intent within the last 3-5 years. Exceptions are: Curatively treated basal cell/squamous cell skin cancer; carcinoma in situ of the cervix; superficial transitional cell bladder carcinoma * Patients with other major or uncontrolled medical conditions, e.g., myocardial infarction or New York Heart Association (NYHA) Class III/IV heart failure within the last 6 months, stroke, uncontrolled diabetes, uncontrolled autoimmune disease. * WOCBP that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of REM-001 therapy. * WOCBP unwilling to use effective contraception during protocol treatment and for 3 months after last dose of REM-001 therapy.

Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC

NCT07698106

Not yet recruiting

Conditions Triple-Negative Breast Cancer (TNBC)

Phase PHASE1, PHASE2

Enrollment 60

Locations 0 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This study is a phase I/II open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1 inhibitor-pembrolizumab-based neoadjuvant chemotherapy (NAC/P) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).

Design

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

Interventions / Regimen

Drug: Group 1-Isunakinra — isunakinra at a dose of 50mg SC daily x 24 weeks in addition to standard pembrolizumab-based neoadjuvant chemotherapy (NAC/P).

Primary Outcomes

Outcome-Study will test whether IL1 blockade can reduce TAM and sensitize human TNBCs to ICB. Outcome measure-changes in the TME induced by the addition of isunakinra to NAC/P will be determined. (6 years)

Study Information

Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Not yet recruiting
Start Date: 2026-08
Completion: 2034-08

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: University Health Network, Toronto
Collaborators: Buzzard Pharmaceuticals

Contact Information

Study Contact:

Michael Reedijk, MD

416-946-4432

Michael.Reedijk@uhn.ca

Interventions

Drug: Group 1-Isunakinra — isunakinra at a dose of 50mg SC daily x 24 weeks in addition to standard pembrolizumab-based neoadjuvant chemotherapy (NAC/P).

Eligibility Criteria

Inclusion Criteria: 1. Age \> 18 years 2. Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment: Clinical stage T1c/N1-N2, T2-4/N0-2 3. Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Demonstrates adequate organ function 6. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study Exclusion Criteria: 1. Male Gender 2. Luminal A/B and HER2 positive breast cancer 3. Multifocal early breast cancer 4. History of invasive malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer 5. Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months 6. Has received prior therapy with an anti-PD1, anti-PDL1/-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor 7. Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study 8. Pre-existing inflammatory arthritis 9. Has received a live vaccine within 30 days of the first dose of study treatment 10. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) 11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment 12. Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C 13. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis 14. Has an active infection requiring systemic therapy 15. Has significant cardiovascular disease 16. Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study 17. Has a known history of active tuberculosis (TB, Bacillus Tuberculosis) 18. Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L 19. ECOG≥2 20. History of stroke or intracranial hemorrhage within 6 months prior to enrollment 21. Presence of moderate or severe renal function impairment (estimated creatinine clearance \<60 mL/min/1.73m2) 22. Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin \> 23 umol/L, serum albumin \< 35 g/L, INR \> 1.70) 23. Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product

Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)

NCT03513614

Active, positions filled

Conditions Node-positive Breast Cancer

Phase NA

Enrollment 1500

Locations 64 sites

Compensation Compensation typically provided

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy. PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.

Design

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

Interventions / Regimen

Procedure: Tailored axillary surgery - both Arms — Axillary lymph node dissection - Arm A
Radiation: Radiotherapy - Arm A — Regional nodal irradiation excluding the dissected axilla - Arm A
Radiation: Radiotherapy - Arm B — Regional nodal irradiation including the full axilla - Arm B

Primary Outcomes

Disease-free survival (DFS) (at the occurrence of the event or latest 20 years after randomization of the last patient)

Study Information

Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2018-08-07
Completion: 2036-12

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1500 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: University Hospital, Basel, Switzerland
Collaborators: ETOP IBCSG Partners Foundation, Austrian Breast Cancer Study Group

Principal Investigators:

Walter P. Weber, Prof. (STUDY_CHAIR) - University Hospital, Basel, Switzerland

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Procedure: Tailored axillary surgery - both Arms — Axillary lymph node dissection - Arm A
Radiation: Radiotherapy - Arm A — Regional nodal irradiation excluding the dissected axilla - Arm A
Radiation: Radiotherapy - Arm B — Regional nodal irradiation including the full axilla - Arm B

Study Locations (64 sites)

Walter Reed National Military Medical Center, Bethesda, Maryland 20814 United States

Duke University/Duke Cancer Center, Durham, North Carolina 27710 United States

Swedish Cancer Institute, Seattle, Washington 98104 United States

Sanatorio Parque Breast Cancer Center, Rosario, Santa Fe Province S2000 Argentina

Institute of Oncology "Angel H. Roffo, Buenos Aires, C1417 Argentina

Krankenhaus Dornbirn, Dornbirn, 6850 Austria

Landeskrankenhaus Feldkirch, Feldkirch, 6800 Austria

Medical University of Innsbruck, Department of Gynecology, Innsbruck, 6020 Austria

Ordens Kinikum Linz, Barmherzige Schwestern, Linz, 4010 Austria

Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU, Salzburg, 5020 Austria

Eligibility Criteria

Inclusion Criteria: Inclusion criteria at pre-registration: * Written informed consent according to ICH/GCP regulations prior to any trial specific procedures. * Breast cancer, node positive detected by palpation or imaging (with or without planned neoadjuvant treatment) * Female or male aged ≥ 18 years * Ability to complete the Quality of Life questionnaires Inclusion criteria at registration: * Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC \[42\] stage II-III (all molecular subtypes allowed): * Node-positivity detected by imaging (iN+) and confirmed by pathology * Node-positivity detected by palpation (cN1-3) and confirmed by pathology * Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present * Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section and either: * Newly diagnosed * Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT * Most suspicious axillary lymph node clipped * Baseline Quality of Life questionnaire has been completed * WHO performance status 0-2 * Adequate condition for general anesthesia and breast cancer surgery * Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and thereafter during the time recommended by the guidelines for adjuvant systemic therapies. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential. * Men agree not to father a child during trial treatment and thereafter during 6 months. Inclusion criteria at randomization (intraoperatively) * Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC stage II-III (all molecular subtypes allowed): * Node-positivity initially detected by imaging and non-palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in SLN or non SLN in case of prior neoadjuvant treatment * Node-positivity initially palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in case of prior neoadjuvant treatment * Note: patients with ypN0(i+) can be included (the AJCC stage II-III refers to the stage before neoadjuvant treatment) \*\*Note: If the fine needle aspiration or core biopsy of the clipped node after neoadjuvant treatment unequivocally shows cancer, repeated confirmation of residual disease by intraoperative frozen section is not mandatory Exclusion Criteria: Exclusion criteria at pre-registration: Any potential patient who meets any of the following criteria has to be excluded from entering the trial. * Stage IV breast cancer * Clinical N3c breast cancer (clinical N3a and clinical N3b are allowed) * Clinical N2b breast cancer (clinical N2a is allowed) * Contralateral breast cancer within 3 years Note: Contralateral Ductal Carcinoma In Situ (DCIS) is allowed if prior treatment does not interfere with or compromise the trial treatment * Prior axillary surgery (except prior sentinel node procedure in case of in- breast recurrence) * Prior regional radiotherapy * History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer. * Treatment with any experimental drug within 30 days of pre-registration * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. Exclusion criteria at randomization (intraoperatively): Any potential patient who meets any of the following criteria has to be excluded from the trial. * Absence of clip in the specimen radiography * Palpable disease left behind in the axilla after Tailored Axillary Surgery (TAS) * No SLN identified in the axilla

FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer

NCT04174352

Recruiting

Conditions ERα+ Breast Cancer, ESR1 Gene Mutation

Phase EARLY_PHASE1

Enrollment 12

Locations 2 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always "turned on" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. \[18F\]-fluoroestradiol Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.

Design

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

Interventions / Regimen

Drug: Tamoxifen — estrogen modulator
Diagnostic Test: FES PET/CT — Radiolabeled estrogen \[18F\]-fluoroestradiol (FES) in combination with Positron Emission Tomography / Computed Tomography is a molecular imaging technique for measuring pharmacodynamic effects of endocrine therapy. The injected dose of 18F-FES will be 6 mCi (185 MBq) ± 20% with a specific activity greater than 170 Ci/mmol at the time of injection for an activity dose of 6 mCi. Participant will receive baseline imaging and repeat imaging after 3-4 weeks to evaluate for FES blockade as assigned dose level.

Primary Outcomes

Rate of FES Blockade at each dose level to determine the Optimal Tamoxifen Dose (up to 6 weeks to compare baseline and treatment images)

Study Information

Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2020-10-20
Completion: 2027-12

Eligibility

Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: University of Wisconsin, Madison

Principal Investigators:

Kari Wisinski, MD (PRINCIPAL_INVESTIGATOR) - University of Wisconsin, Madison

Contact Information

Study Contact:

cancer connect

800-622-8922

clinicaltrials@cancer.wisc.edu

Interventions

Drug: Tamoxifen — estrogen modulator
Diagnostic Test: FES PET/CT — Radiolabeled estrogen \[18F\]-fluoroestradiol (FES) in combination with Positron Emission Tomography / Computed Tomography is a molecular imaging technique for measuring pharmacodynamic effects of endocrine therapy. The injected dose of 18F-FES will be 6 mCi (185 MBq) ± 20% with a specific activity greater than 170 Ci/mmol at the time of injection for an activity dose of 6 mCi. Participant will receive baseline imaging and repeat imaging after 3-4 weeks to evaluate for FES blockade as assigned dose level.

Study Locations (2 sites)

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin 53792 United States

Wisconsin Oncology Network (WONIX) sites, Madison, Wisconsin 53792 United States

Eligibility Criteria

Inclusion Criteria: * Participants must have histologically confirmed breast cancer that is metastatic or unresectable with the following: * Estrogen receptor expression by immunohistochemistry greater than or equal to 10% * ESR1 mutation identified using a Clinical Laboratory Improvement Amendments (CLIA) certified assay via tumor biopsy tissue or circulating free DNA (cfDNA) * human epidermal growth factor receptor 2 (HER2) negative * Participants must have measurable disease as defined by RECIST 1.1 or evaluable bone disease with at least one lesion measuring 10 mm or greater in size. (Participants with bone and non-bone disease are eligible. One disease site must meet either the measurable or evaluable criteria outlined.) Participants with liver-only disease are not eligible due to the inherent hepatic uptake related to the radiopharmaceutical's hepatobiliary route of elimination. * Participants must have received at least 1 prior line of endocrine therapy in the metastatic setting or have had progression within 12 months of adjuvant endocrine therapy. Prior Tamoxifen is allowed in any setting. Prior CDK4/6 in the metastatic setting per NCCN guidelines is allowed. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (See Appendix A) * Life expectancy of greater than 12 weeks. * Ability to take oral medications. * Informed consent: participant must be informed of the investigational nature of the study and must be able to sign a written informed consent. * Participants with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at least 1 month. * Participants must have adequate normal organ and bone marrow function as defined below: * Absolute neutrophil count \>/= 1,000/mcL * Hemoglobin \>/= 9.0 g/dL * Platelets \>/= 100,000/mcL * Total bilirubin \</= 1.5 x upper limit of normal (ULN) * AST (SGOT)/ ALT (SGPT) \</= 2.5 x ULN; \</= 5 x ULN in the setting of metastatic liver disease * Creatinine \</= 1.5 x ULN or creatinine clearance \>/= 50 mL/min Exclusion Criteria: * Prior chemotherapy, radiotherapy, targeted, immunotherapy or investigational therapy within 2 weeks or major surgery within 4 weeks of study enrollment or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events due to agents administered more than 2 weeks earlier (alopecia and fatigue excluded). * Participants must not be receiving an ER blocking endocrine therapy (includes fulvestrant, tamoxifen, toremifene, raloxifene) and must be off the agents for a minimum of 60 days prior to planned FES PET/CT to allow for adequate uptake of FES. * History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of tamoxifen or \[18F\]-fluoroestradiol. * Peripheral neuropathy of severity greater than grade 1. * Current optic nerve disorders, retinopathy, lattice degeneration, macular degeneration, retinal vascular disorder, or retinal tears of severity greater than grade 1. * History of cerebellar disorders, ataxia, and uncontrolled seizures unless related to transient medical condition and in investigator's opinion is not an active medical issue. * History of venous thrombosis/thromboembolic event, including pulmonary embolism and stroke. * Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 470msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, chronic hypokalemia, family history of long QT interval syndrome). * Are taking medications that are known to prolong the QT interval, unless they can be transferred to other medications ≥ 5 half-lives prior to dosing or unless the medications can be properly monitored during the study. If equivalent medication is not available, QTcF should be closely monitored. * Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant women. Tamoxifen use during pregnancy may have a potential long-term risk to the fetus of a Diethylstilbestrol syndrome (DES)-like syndrome. Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative urine/serum pregnancy test within 14 days of tamoxifen treatment). In addition, a medically acceptable method of birth control must be used such as an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 3 months after last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP. * Ongoing treatment with other investigational agents. Participants cannot be receiving concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment. * History of uterine malignancy unless participant has had hysterectomy with no evidence recurrent disease for ≥ 3 years from definitive therapy. * Concurrent malignancy except for the following: * Basal cell or squamous cell skin cancer * In situ cervical cancer * The following medications are contraindicated or must be used with caution. * Contraindicated: * CYP2D6, CYP3A4, and CYP2C9 strong inhibitors * CYP2D6, CYP3A4, and CYP2C9 strong inducers * Use with caution: * CYP2C9 sensitive substrates * CYP2D6 moderate inhibitors or inducers * CYP3A4 moderate inhibitors or inducers Note: Transdermal products designed for systemic delivery must be assessed for interaction potential. Topical products not designed to provide systemic delivery (including inhaled products, ophthalmologic products and transvaginal preparations) do not need to be considered. Contraindicated medications are not allowed. Participants taking these concurrent medications are ineligible unless they can discontinue or switch to alternative medications prior to initiation of study drug (at least 5 half-lives). Use with caution agents are permitted if a) discontinuation is not feasible or b) no acceptable alternatives are available as determined by the treating physician; however, caution should be used. Consider monitoring by symptoms, labs or drug levels and dose adjustments of the medication. * Uncontrolled intercurrent clinically significant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

NCT06942234

Recruiting

Conditions Inoperable Locally Advanced HER2-Negativ...

Phase PHASE1, PHASE2

Enrollment 180

Locations 1 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.

Design

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

Interventions / Regimen

Drug: JSKN016 — JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Drug: Capecitabine — The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.
Drug: Paclitaxel (albumin bound) — The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Drug: Eribulin — The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Drug: Pembrolizumab — The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.

Primary Outcomes

Objetctive Response Rate (ORR) (From baseline until disease progression, death, or end of treatment, whichever occurs first (up to approximately 24 months))

Study Information

Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-06-01
Completion: 2027-12-31

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Contact Information

Study Contact:

Jian Zhang

+86-21-64175590

syner2000@126.com

Interventions

Drug: JSKN016 — JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.
Drug: Capecitabine — The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.
Drug: Paclitaxel (albumin bound) — The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Drug: Eribulin — The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.
Drug: Pembrolizumab — The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.

Study Locations (1 sites)

Fudan University Shanghai Cancer center, Shanghai, China

Eligibility Criteria

Inclusion Criteria: 1. Capable of understanding and signing the informed consent form. 2. Aged ≥18 and ≤75 years, regardless of sex. 3. Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer. 4. Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it. 5. Disease progression confirmed by radiological evidence post-systemic treatment. 6. Available archived or newly obtained tumor tissue/biopsy. 7. No prior systemic therapy for advanced disease, except for prior endocrine ± targeted therapy or CDK4/6 inhibitors. 8. Measurable non-CNS lesion per RECIST 1.1. 9. Expected survival ≥3 months. 10. ECOG performance status of 0 or 1. 11. Contraceptive use agreement for fertile participants. 12. Adequate organ function within 7 days of enrollment: * Bone marrow: ANC ≥1.5 × 10⁹/L, Hemoglobin ≥90 g/L, Platelets ≥100 × 10⁹/L. * Liver: Bilirubin ≤1.5 × ULN, ALT/AST ≤3 × ULN. * Renal: Creatinine ≤1.5 × ULN or Ccr ≥60 mL/min. * Coagulation: INR/PT ≤1.5 × ULN, APTT ≤1.5 × ULN. 13. LVEF ≥50%. Exclusion Criteria: 1. CNS metastasis (except stable cases treated with radiation or surgery). 2. Unstable spinal cord compression or untreated history. 3. Recent live vaccine (except seasonal flu vaccines). 4. Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter). 5. Recent palliative therapy within 14 days. 6. Major surgery within 28 days or planned during the study. 7. Severe gastrointestinal issues or recent major GI bleeding. 8. Uncontrolled pleural/peritoneal effusions or cachexia. 9. Prior HER3/TROP2-targeted therapy or topoisomerase I inhibitors. 10. Other malignancies within 5 years (except certain skin or localized cancers). 11. Current interstitial lung disease or uncontrolled infections. 12. Severe hypercalcemia or uncontrolled cancer-related pain. 13. Autoimmune diseases, unless stable with treatment. 14. Uncontrolled comorbidities (e.g., active infections, cardiovascular issues). 15. Toxicities from previous treatments not resolved to CTCAE ≤1. 16. Recent steroid use or need for systemic immunosuppressive therapy. 17. Allergy to study drug components. 18. Pregnancy or breastfeeding.

Exemption of SLNB After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer

NCT07498400

Active, positions filled

Conditions Breast Cancer (Triple Negative Breast Ca...

Phase NA

Enrollment 216

Locations 1 sites

Compensation Compensation typically provided

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The neoadjuvant system therapy (NAST) can significantly increase the pathological complete response (pCR) rate for patients with triple-negative (TNBC) and HER2-positive breast cancer. Some patients can achieve complete disappearance of the tumor or only residual tumors ≤ 2 cm in preoperative imaging examinations (mammography, ultrasound or MRI), which is defined as clinical complete response (cCR). The traditional surgical approach still requires sentinel lymph node biopsy (SLNB) even for cCR cases to rule out axillary metastasis. However, the association of SLNB with complications such as lymphedema, pain, and limited shoulder joint function has been confirmed in multiple retrospective cohorts, significantly reducing the quality of life of patients. Current guidelines (such as ASCO 2025, SOUND, INSEMA) propose that SLNB can be omitted in low-risk populations, but these recommendations are mainly based on postoperative pathological information (pCR) or overall survival (OS)/progression-free survival (DFS), and lack high-level evidence for the direct assessment of axillary lymph node recurrence rate (AR). Therefore, there is an urgent need to conduct prospective, randomized controlled trials to clarify whether omitting SLNB will lead to an increase in axillary recurrence in T1-2 N0 triple-negative or HER2-positive breast cancer patients who achieve cCR after neoadjuvant treatment. The results of this study will provide evidence-based support for surgical de-radication, potentially significantly reducing surgical-related complications, saving medical resources, and improving the quality of life of patients.

Design

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

Interventions / Regimen

Procedure: Exemption of SLNB — Breast-conserving surgery (or mastectomy) without sentinel lymph node biopsy (SLNB). Postoperatively, conventional radiotherapy (for breast-conserving therapy), endocrine (HR+) immunotherapy (for triple-negative cases), or HER2-targeted (HER2+) treatment is received.

Primary Outcomes

Efficacy Measurement (3 years)

Study Information

Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2026-01-01
Completion: 2031-03-01

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 216 (ACTUAL)

Sponsor & Investigators

Lead Sponsor: Xijing Hospital

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Procedure: Exemption of SLNB — Breast-conserving surgery (or mastectomy) without sentinel lymph node biopsy (SLNB). Postoperatively, conventional radiotherapy (for breast-conserving therapy), endocrine (HR+) immunotherapy (for triple-negative cases), or HER2-targeted (HER2+) treatment is received.

Study Locations (1 sites)

Xijing Hospital, Xi'an, China

Eligibility Criteria

Inclusion Criteria: 1. Female, aged 18 to 70 years; 2. Histologically diagnosed with invasive breast cancer, clinical stage T1-T2 (tumor maximum diameter ≤ 5 cm), clinical assessment as cN0 (physical examination + at least two negative imaging tests, including axillary ultrasound, and MRI or PET CT when necessary); 3. Immunohistochemistry or ISH confirmed as HER2 positive (IHC 3+ or ISH positive) or triple-negative (ER, PR, HER2); 4. Completed a standardized neoadjuvant chemotherapy regimen (including HER2-targeted or immune checkpoint inhibitors), and was assessed as clinical complete response (CCR) before surgery; 5. No residual masses on physical examination; 6. Imaging (MMG/US/MRI) shows the tumor ≤ 2 cm or complete disappearance; 7. Preoperative or intraoperative biopsy (when necessary) confirmed no residual invasive cancer. 8. ECOG 0-1, and expected to be able to receive whole breast radiotherapy after breast-conserving surgery. 9. Voluntarily signed a written informed consent. Exclusion Criteria: 1. Tumor-related symptoms and treatment 1) Patients with metastatic breast cancer or bilateral breast cancer; 2) Patients with inflammatory breast cancer; 3) Patients with multiple lesion sites; 2. Comorbid diseases/medical history 1) Previously had other malignant tumors and received any systemic anti-tumor treatment or local treatment (including surgery and radiotherapy), excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors; 2) Within 4 weeks before enrollment, had undergone major surgeries unrelated to breast cancer or the patient had not fully recovered from such surgeries (biopsy for diagnostic purposes and peripheral venous puncture for central venous catheter insertion \[PICC\] are allowed); 3) Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; autoimmune hepatitis; 4) Previously or preparing to undergo allogeneic bone marrow transplantation or solid organ transplantation; 6) Severe heart disease or discomfort, including but not limited to the following diseases: * History of diagnosed heart failure or systolic dysfunction (LVEF \< 50%) * High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e. Mobitz II second-degree atrioventricular conduction block or third-degree atrioventricular conduction block) * Angina pectoris requiring anti-anginal drug treatment * Clinically significant heart valve disease * ECG showing transmural myocardial infarction * Poorly controlled hypertension (systolic pressure \> 180 mmHg and/or diastolic pressure \> 100 mmHg) 3. Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results or fertile women patients who are unwilling to take effective contraceptive measures throughout the trial period. 4. Previously had a clear history of neurological or mental disorders, including epilepsy or dementia, and the subjects were known to have a history of substance abuse of psychotropic drugs, alcoholism or drug abuse; Other conditions that the investigator considers make the patient unsuitable to participate in this study.

Safety and Efficacy of IMPT or IMRT for Breast Cancer

NCT06826885

Recruiting

Conditions Breast Cancer, Proton Therapy, Intensity...

Phase Not Applicable

Enrollment 500

Locations 1 sites

Compensation reimbursement available

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Design

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

Interventions / Regimen

Radiation: Postoperative radiotherapy — Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions.
Radiation: Preoperative Radiotherapy — Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed.
Radiation: Definitive Radiotherapy — Radiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4.

Primary Outcomes

Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity (6 months)

Study Information

Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-12-01
Completion: 2029-11-30

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Ruijin Hospital
Collaborators: Shandong Cancer Hospital and Institute, Sichuan Cancer Hospital and Research Institute, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Tongji Hospital

Principal Investigators:

Gang Cai, MD (PRINCIPAL_INVESTIGATOR) - Ruijin Hospital
Jia-Yi Chen, PhD, MD (STUDY_CHAIR) - Ruijin Hospital

Contact Information

Study Contact:

Gang Cai, MD

+86-021-64370045

cg11855@rjh.com.cn

Lu Cao, PhD, MD

+86-021-64370045

chenjiayi0188@aliyun.com

Interventions

Radiation: Postoperative radiotherapy — Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions.
Radiation: Preoperative Radiotherapy — Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed.
Radiation: Definitive Radiotherapy — Radiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4.

Study Locations (1 sites)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality 200025 China

Eligibility Criteria

Inclusion Criteria * Aged ≥18 years old * Karnofsky Performance Status (KPS) score ≥70 * Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician. * ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor. * Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation. * Ability to understand and willingness to participate in the research and sign the informed consent form. Exclusion Criteria * Pregnant or lactating women. * Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation. * Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity. * Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.

LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training

NCT07539649

Not yet recruiting

Conditions Survivorship

Phase NA

Enrollment 48

Locations 0 sites

Compensation Compensation typically provided

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).

Design

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

Interventions / Regimen

Behavioral: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program — LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program

Primary Outcomes

PROMIS Depression Short Form (8a) (Baseline (week 0), post-intervention (week 11), and 1-month follow-up (week 15))
PROMIS Anxiety Short Form (7a) (Baseline (week 0), post-intervention (week 11), and 1 month follow-up (week 15))

Study Information

Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-09-30
Completion: 2027-02-28

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 48 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Medical University of South Carolina
Collaborators: American Cancer Society, Inc.

Principal Investigators:

Kelly Hyland, PhD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina

Contact Information

Study Contact:

Kathryn Moody

843-792-9698

moodykat@musc.edu

Benjamin Axelrod

843-876-2645

axelrod@musc.edu

Interventions

Behavioral: LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program — LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program

Eligibility Criteria

Inclusion Criteria: 1. identify as female 2. be diagnosed with metastatic (AJCC stage IV) breast cancer 3. be receiving care for metastatic breast cancer at Hollings Cancer Center 4. endorse \>3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist 5. be \> 18 years of age 6. be able to understand, speak, and read English 7. be able to provide informed consent. Exclusion Criteria: 1. reported or suspected cognitive impairment 2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist 3. expected survival \<6 months, as indicated by a hospice referral

Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients

NCT06635447

Active, positions filled

Conditions Breast Cancer

Phase PHASE3

Enrollment 293

Locations 76 sites

Compensation Phase 3: Typically $200-$1,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy. The Primary objective is to assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1.

Design

Study type: Interventional Phases: Phase3 Allocation: Non Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

Drug: Capivasertib — 400 mg, oral, twice daily; 4 days on and 3 days off
Drug: Fulvestrant — Fulvestrant IV

Primary Outcomes

Time to first subsequent treatment (TFST) of PIK3CA/AKT1/PTEN-altered population in Cohort 1 (From the first dose of study intervention to the earlier of start date of the first subsequent therapy after discontinuation of study intervention, or death in PIK3CA/AKT1/PTEN-altered population in Cohort 1, up to approximately 2 years)

Study Information

Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2024-09-26
Completion: 2027-01-10

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 293 (ACTUAL)

Sponsor & Investigators

Lead Sponsor: AstraZeneca

Principal Investigators:

Zefei Jiang, PhD (PRINCIPAL_INVESTIGATOR) - Clinical Trial Ethics Committee of The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Contact Information

No direct contact listed - use the ClinicalTrials.gov link below to reach the study team

Interventions

Drug: Capivasertib — 400 mg, oral, twice daily; 4 days on and 3 days off
Drug: Fulvestrant — Fulvestrant IV

Study Locations (76 sites)

Research Site, Baoding, 071000 China

Research Site, Beijing, 100021 China

Research Site, Beijing, 100071 China

Research Site, Beijing, 100730 China

Research Site, Beijing, CN-100730 China

Research Site, Bengbu, 233004 China

Research Site, Changchun, 130021 China

Research Site, Changsha, 410008 China

Research Site, Changsha, 410011 China

Research Site, Changsha, 410013 China

Eligibility Criteria

Inclusion Criteria 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP). 2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses. 3. Patients must be aged ≥18 years at the time of signing the ICF 4. Adult females, pre- and/or post-menopausal, and adult males -Pre-menopausal (and peri-menopausal i.e., those that do not meet the criteria for post-menopausal defined below) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study -Post-menopausal women are defined as: a)aged ≥60 years of age, or b)aged \<60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments/chemotherapy/ovarian suppression/tamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, or c)documented bilateral oophorectomy 5. Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor. 1)ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3/8, 2)Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3/8; or progesterone receptor negative defined as \<1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2/8; or progesterone receptor unknown, 3)or the investigator assesses the condition as HR+ status and 4)HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH. Metastatic or locally advanced disease with radiographic or objective evidence of recurrence or progression (cancer that has progressed during or after a recent treatment period).; locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible) Patients are to have received treatment with an endocrine therapy containing regimen (single agent or in combination) and have: a)Radiological evidence of breast cancer recurrence or progression during treatment or within 12 months after the end of treatment with a neoadjuvant or adjuvant endocrine therapy, OR b)Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy) (for patients with breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET will be limited to approximately 10%). 6. Patients must have at least 1 measurable lesion. 7. Patients must be eligible for fulvestrant therapy as per local investigator assessment. 8. Consent to submit and provide a mandatory FFPE tumour sample for central testing. 9. Patients must be able to swallow and retain oral medication. 10. Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status 0 or 1 and life expectancy of ≥12 weeks. 11. Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients enrolled under Protocol Version 2.0.) Exclusion Criteria 1. A disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life-threatening in the short-term) 2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. Radiotherapy within 2 weeks prior to the first dose of study intervention. Major surgery (excluding placement of vascular access) within 4 weeks prior to study treatment initiation 3. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment 4. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation 5. Leptomeningeal metastase 6. Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice). 7. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease 8. Any of the following cardiac criteria: a)Mean resting QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from 3 consecutive ECGs b)History of QT prolongation associated with other medications that required discontinuation of that medication. - Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block) c)Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended. d)Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, clinically significant electrolyte abnormalities including hypokalaemia, hypomagnesaemia, and hypocalcaemia, potential for Torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval e)Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris, f)Congestive heart failure New York Heart Association (NYHA) grade ≥2 9. Clinically significant abnormalities of glucose metabolism defined as HbA1c ≥8.0% (63.9 mmol/mol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines. 10. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: a)Absolute neutrophil count \<1.5 × 109/L b)Platelet count \<100 × 109/L c)Haemoglobin \<9 g/dL (\<5.59 mmol/L). \[NOTE: any blood transfusion must be \>14 days prior to the determination of a haemoglobin ≥9 g/dL (≥5.59 mmol/L)\] d)Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \>2.5 times upper lim

[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)

NCT07020806

Recruiting

Conditions Metastatic Lobular Breast Carcinoma

Phase PHASE1

Enrollment 30

Locations 1 sites

Compensation Phase 1: Typically $1,000-$5,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).

Design

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

Interventions / Regimen

Drug: [68Ga]Ga DOTA-5G — Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.

Primary Outcomes

The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions (2 hours from time of injection)
Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0 (Up to 7 days from time of injection)

Study Information

Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-11-18
Completion: 2027-06

Eligibility

Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: University of California, Davis
Collaborators: Dr. Helen K Chew, University of California Davis, Dr. Cameron Foster, University of California Davis, Society of Nuclear Medicine and Molecular Imaging

Principal Investigators:

Julie Sutcliffe, PhD (PRINCIPAL_INVESTIGATOR) - University of California, Davis

Contact Information

Study Contact:

Julie Sutcliffe, PhD

916-734-5536

jlsutcliffe@ucdavis.edu

Interventions

Drug: [68Ga]Ga DOTA-5G — Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.

Study Locations (1 sites)

University of California Davis, Sacramento, California 95817 United States

Eligibility Criteria

Inclusion Criteria: * (Ability to understand and willingness to sign a written informed consent document. * Men and women age ≥ 18 yrs * Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST * Available archival tumor tissue * Eastern Cooperative Oncology Group Performance Status ≤ 2 * Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3,Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL. * Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN), Total bilirubin ≤ 2 times ULN, eGFR \>60 mL/min/1.73m\*2 * Anticipated life expectancy ≥ 3 months * Able to remain motionless for up to 30-60 minutes per scan. Exclusion Criteria: * Pregnant and lactating women * Prisoners * Concurrent malignancy of a different histology that could confound imaging interpretation. * Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)

A Study of the TheraBionic P1 Device in Breast Cancer

NCT07218432

Recruiting

Conditions Breast Cancer Stage I, Breast Cancer Sta...

Phase NA

Enrollment 24

Locations 8 sites

Compensation Compensation typically provided

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.

Design

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

Interventions / Regimen

Device: TheraBionic P1 Device — Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.

Primary Outcomes

Pathological Response to Treatment (At time of surgery (after approximately 2 weeks of treatment and tumor resection))

Study Information

Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-10
Completion: 2028-06-30

Eligibility

Age: 22 Years
Sex: FEMALE
Volunteers: false
Enrollment: 24 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Principal Investigators:

Lubina Arjyal, M.D. (PRINCIPAL_INVESTIGATOR) - Wayne State University

Contact Information

Study Contact:

Lubina Arjyal, M.D.

1-800-karmanos

arjyall@karmanos.org

Interventions

Device: TheraBionic P1 Device — Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.

Study Locations (8 sites)

Karmanos Cancer Institute at McLaren Clarkston, Clarkston, Michigan 48346 United States

Karmanos Cancer Institute, Detroit, Michigan 48201 United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills, Michigan 48334 United States

Karmanos Cancer Institute at McLaren Flint, Flint, Michigan 48532 United States

Karmanos Cancer Institute at McLaren Greater Lansing, Lansing, Michigan 48910 United States

Karmanos Cancer Institute at McLaren Lapeer Region, Lapeer, Michigan 48466 United States

Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey, Michigan 49770 United States

Karmanos Cancer Institute at McLaren Port Huron, Port Huron, Michigan 48060 United States

Eligibility Criteria

Inclusion Criteria: * Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) \>1% and HER2 negative by immunohistochemistry \[IHC\] and/or fluorescent in situ hybridization \[FISH\]). * Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery. * Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection * Participant must have archival tissue available. * Participant must be a woman aged 22 years or older * Participant must be able to understand a written informed consent document and be willing to sign it * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session Exclusion Criteria: * Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy * Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints * Participants that are taking any other investigational drugs * Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued * Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae). * Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid/vitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study. * Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device * Participants with a known severe (e.g., anaphylactic) allergy to nickel.

A Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer

NCT07385365

Not yet recruiting

Conditions Breast Cancer

Phase PHASE3

Enrollment 3142

Locations 1 sites

Compensation Phase 3: Typically $200-$1,000

Data Updated 2026-09-08

Click to view full details

View Official Listing I'm Interested

Study Details Design, interventions, and primary outcomes

Loading study details from ClinicalTrials.gov…

Study details are not available yet for this trial.

About This Study

The research hypothesis is that the tumor-free survival rate of intermediate-risk breast cancer patients exempted from RNI is not inferior to that of those receiving RNI. Patients with intermediate-risk breast cancer have a relatively low local-regional recurrence rate whether they undergo RNI or not.Patients were randomly assigned to the RNI group and the non-RNI group.After radiotherapy,the patients are followed the efficacy and toxicities of radiotherapy are evaluated.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

Radiation: Regional nodal Radiotherapy — postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
Radiation: Non-Regional nodal Radiotherapy — conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.

Primary Outcomes

tumor-free survival rate (5 year)

Study Information

Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2026-02-01
Completion: 2042-12-31

Eligibility

Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 3142 (ESTIMATED)

Sponsor & Investigators

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Contact Information

Study Contact:

Shu-Lian Wang, M.D.

+86-010-87787659

wangsl@cicam.ac.cn

Interventions

Radiation: Regional nodal Radiotherapy — postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
Radiation: Non-Regional nodal Radiotherapy — conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.

Study Locations (1 sites)

Cancer Hospital,Chinese Academy od Medical Sciences, Beijing, Beijing Municipality China

Eligibility Criteria

Inclusion Criteria: * Female patients aged 18 or above * Undergo breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy * The surgical margin was negative * Tumor stage:Patients who receive direct surgery : pT1-2N1M0, with at least one lymph node having macrometastasis and a tumor risk score of 0-2.For those who underwent surgery after neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0 (cN+ with pathological confirmation), neoadjuvant Chemotherapy for ≥6 cycles. Exclusion Criteria: * distant metastasis * metastasis of ipsilateral internal mammary, supraclavicular or subclavian lymph nodes * Had received chest radiotherapy in the past * Bilateral breast cancer * Pregnancy or lactation period * Other malignant tumors in the past or at the same time, and the tumor-free survival time is less than 5 years (excluding non-malignant melanoma skin cancer, papillary thyroid carcinoma/follicular carcinoma, cervical carcinoma in situ)

Find Clinical Trials

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen

Primary Outcomes

About This Study

Design

Interventions / Regimen