University of California, San Francisco
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.
PRIMARY OBJECTIVES: I. Real-world progression free survival (rwPFS) of the first line of ADC under routine care (ADC1) by investigator assessment II. Real-world progression free survival (rwPFS) of the second line ADC under routine care (ADC2) by investigator assessment SECONDARY OBJECTIVES: I. To evaluate the efficacy of ADC1 and ADC2 as measured by duration of response (DOR), best overall response (BOR), disease control rate (DCR), and overall survival (OS) for each ADC. II. To evaluate key safety parameters for ADC1 and ADC2 by chart review. EXPLORATORY OBJECTIVES: I. To evaluate/iden…
Inclusion Criteria: 1. Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study. 2. Estimated life expectancy of at least at 3 months per investigator assessment. 3. Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes. 4. Cohort-specific enrollment criteria: * Cohort 1: Histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their first ADC per standard of care (SOC). * Cohort 2: Histologically…
Blood specimens will be collected during regular clinical visits for correlative and exploratory analysis
ADC given under usual care for the treatment of cancer
Prospective and retrospective medical chart reviews will be conducted to obtain data for analysis.
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