Actively Recruiting
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
Led by University of California, San Francisco · Updated on 2025-12-18
100
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
T
Translational Breast Cancer Research Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or greater who can provide written informed consent
- Estimated life expectancy of at least 3 months according to investigator assessment
- Willingness to provide archival tissue and multiple blood samples (20cc each) for research
- Cohort 1: Histologically confirmed HR+/HER2- metastatic breast cancer with plan to start an FDA-approved ADC as first ADC
- Cohort 2: Histologically confirmed metastatic triple negative breast cancer with plan to start an FDA-approved ADC as first ADC
- Cohort 3: Histologically confirmed HR+/HER2- metastatic breast cancer with plan to start an FDA-approved ADC as second ADC; prior first ADC must be FDA-approved given per standard care or monotherapy in clinical trial; no prior experimental ADCs; clinical data from first ADC available
- Cohort 4: Histologically confirmed metastatic triple negative breast cancer with plan to start an FDA-approved ADC as second ADC; prior first ADC must be FDA-approved given per standard care or monotherapy in clinical trial; no prior experimental ADCs; clinical data from first ADC available
- Measurable disease is not required for any cohort
You will not qualify if you...
- Prior receipt of an experimental antibody-drug conjugate (ADC) in the metastatic setting
- Current participation in a clinical trial involving an ADC
- Contraindication to research blood draws of approximately 20cc at each research timepoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
A
Amy Langdon
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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