NCT06774027 Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
| NCT ID | NCT06774027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | HER2-negative Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-10-08 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Laura Huppert, MD,BA
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06774027 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06774027 currently recruiting?
Yes, NCT06774027 is actively recruiting participants. Contact the research team at Amy.Deluca@ucsf.edu for enrollment information.
Where is the NCT06774027 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06774027 clinical trial?
NCT06774027 is sponsored by University of California, San Francisco. The principal investigator is Laura Huppert, MD,BA at University of California, San Francisco. The trial plans to enroll 100 participants.
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