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.
Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study.
Estimated life expectancy of at least at 3 months per investigator assessment.
Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes.
Cohort 1: Histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their first ADC per standard of care (SOC).
Prior receipt of an experimental ADC in the metastatic setting. Of note, patients who received an FDA-approved ADC as their first ADC (as monotherapy, not in combination) can participate in cohorts 3 or 4 prior to starting their second FDA-approved ADC per standard of care. Of note, for all cohorts, experimental therapies are not allowed as intervening therapies after starting ADC1. If a patient enrolls on a clinical trial of an experimental therapy after ADC1, they will be taken off study.
Current participation in a clinical trial with an ADC.
Contraindication to research phlebotomy to collect ~20cc blood at each research blood draw timepoint.
University of California, San Francisco
Lead sponsor
Translational Breast Cancer Research Consortium
Collaborator
Gilead Sciences
Collaborator
Johns Hopkins University
Collaborator