Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
NCT06774027 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-12-18
Summary
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC) and hormone receptor positive/HER2 negative (HR+/HER2-) metastatic breast cancer (MBC), offering an effective new treatment strategy. Several outstanding questions drive the decision to use ADC drugs clinically. This is a prospective, multi-site observational study of patients with metastatic breast cancer (mBC) who are being treated with FDA-approved antibody drug conjugates (ADCs) as part of routine care and aims to collect real-world data to evaluate the impact of ADC treatment as part of routine care.
Conditions
- HER2-negative Breast Cancer
- HER2 Negative Breast Carcinoma
- Metastatic Breast Cancer
- HR+ HER2 Breast Cancer
- Metastatic Triple Negative Breast Cancers
- Metastatic Triple-Negative Breast Carcinoma
Interventions
- PROCEDURE
-
Specimen collection
Blood specimens will be collected during regular clinical visits for correlative and exploratory analysis
- DRUG
-
Non-Investigational Antibody-Drug Conjugates (ADC)
ADC given under usual care for the treatment of cancer
- OTHER
-
Medical Record Review
Prospective and retrospective medical chart reviews will be conducted to obtain data for analysis.
Sponsors & Collaborators
-
Translational Breast Cancer Research Consortium
collaborator OTHER - collaborator INDUSTRY
- collaborator OTHER
-
University of California, San Francisco
lead OTHER
Principal Investigators
-
Laura Huppert, MD,BA · University of California, San Francisco
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-08
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
Countries
- United States
Study Locations
More Related Trials
-
Trastuzumab in Combination With AMG 479 in HER-2 Overexpressing MBC Progressing on Trastuzumab
NCT01479179 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
NCT00875979 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
NCT00191373 ·Status: COMPLETED ·Phase: PHASE2
-
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
NCT03321981 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT03424005 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
NCT00193076 ·Status: COMPLETED ·Phase: PHASE2
-
FMT in Triple Negative Breast Cancer Guided by ctDNA
NCT07292142 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
NCT00679211 ·Status: COMPLETED ·Phase: PHASE2
-
Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression
NCT00033514 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
NCT00509769 ·Status: COMPLETED ·Phase: PHASE2
-
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
NCT02422641 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer
NCT01231802 ·Status: UNKNOWN ·Phase: PHASE2
-
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
NCT00010075 ·Status: UNKNOWN ·Phase: PHASE2
-
Herceptin and GM-CSF for Metastatic Breast Cancer
NCT00429104 ·Status: COMPLETED ·Phase: PHASE2
-
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
NCT01276041 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer
NCT01828021 ·Status: COMPLETED ·Phase: PHASE2
-
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)
NCT05928780 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
NCT00036868 ·Status: COMPLETED ·Phase: PHASE2
-
Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer
NCT02598427 ·Status: TERMINATED ·Phase: PHASE1
-
Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab
NCT03135171 ·Status: COMPLETED ·Phase: PHASE1
-
Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab
NCT01730677 ·Status: UNKNOWN ·Phase: PHASE2
-
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
NCT03106077 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
NCT07019337 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
NCT01120561 ·Status: NO_LONGER_AVAILABLE
-
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
NCT03062007 ·Status: TERMINATED ·Phase: PHASE1