Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a new type of treatment called antibody-drug conjugates (ADCs) for patients with advanced breast cancer that is either HER2-negative or hormone receptor-positive/HER2-negative. These treatments have shown promise in helping patients live longer and have fewer complications compared to traditional options. The trial aims to gather real-world information about how effective these ADCs are when used in everyday medical care.

To participate, patients must be at least 18 years old and have a life expectancy of at least three months. They will need to provide some blood samples and, if applicable, tissue samples for research. The study includes different groups of patients: some will be starting their first ADC treatment, while others will be starting their second. Importantly, patients who have previously received experimental ADCs will not be eligible. This trial is not yet recruiting participants, but it aims to provide valuable insights into how ADCs work in real-life settings for those battling metastatic breast cancer.

Gender

ALL

Eligibility criteria

• 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 documented metastatic TNBC with plan to start an FDA-approved ADC as their first ADC per standard of care
• • Cohort 3: Histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per SOC or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.
• • Cohort 4: Histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per standard of care (ADC1 should be an approved ADC administered per standard of care or as monotherapy in a clinical trial; no prior experimental ADCs allowed). Clinical data from the first ADC must be available for retrospective review.
• • Measurable disease is not required for any cohort.
• Exclusion Criteria:
• • 1. 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.
• • 2. Current participation in a clinical trial with an ADC.
• • 3. Contraindication to research phlebotomy to collect \~20cc blood at each research blood draw timepoint.