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.
Adults receiving routine treatment for metastatic breast cancer who have planned, usual care with first line or second line of ADC.
Case-control
Prospective
Specimen collection
Procedure/SurgeryBlood specimens will be collected during regular clinical visits for correlative and exploratory analysis
Non-Investigational Antibody-Drug Conjugates (ADC)
DrugADC given under usual care for the treatment of cancer
Medical Record Review
Other interventionProspective and retrospective medical chart reviews will be conducted to obtain data for analysis.
Real-world progression free survival (rwPFS) of first line ADC (ADC1)
rwPFS is defined as the amount of time that elapses between the initiation of ADC1 therapy until the patient experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever comes first).
rwPFS of second line ADC (ADC2)
rwPFS is defined as the amount of time that elapses between the initiation of ADC2 therapy following a previous line of ADC (ADC1) until the participant experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever comes first).
Median Duration of Response (DOR)
DOR is defined as the amount of time between when measurement criteria are met for complete response (CR) or partial response (PR), whichever is first recorded, until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the usual care ADC began) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The participants response will depend on the achievement of both measurement and confirmation criteria.
Best Overall Response (BOR)
The best overall response is the best response recorded from the start of ADC usual care treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The proportion of participants who experience each the following as a best response to usual care ADC: CR, PR, stable disease (SD), PD or not evaluable (NE) per RECIST 1.1 will be reported. The participants best response will depend on the achievement of both measurement and confirmation criteria
Overall Response Rate (ORR)
The ORR is the best response recorded from the start of ADC usual care treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The proportion of participants who experience either CR or PR during usual care ADC will be reported. The participants response will depend on the achievement of both measurement and confirmation criteria
Disease Control Rate (DCR)
The DCR is defined as the proportion of participants who experience complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 during usual care ADC. The date of first response for either CR, PR, or SD will be used for the calculation of DCR.
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University of California, San Francisco
Lead sponsor
Translational Breast Cancer Research Consortium
Collaborator
Gilead Sciences
Collaborator
Johns Hopkins University
Collaborator
