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Observational Study of ADC Treatments for Metastatic Breast Cancer

This study is looking at how antibody-drug conjugates (ADCs) work in real-world settings for people with metastatic breast cancer (cancer that has spread). It includes those with HER2-negative, HR+ HER2-negative, and triple-negative breast cancer. Researchers will collect information from your medical records and blood samples during your regular doctor visits. They want to see how long people live without their cancer getting worse (called real-world progression-free survival) when treated with ADCs as a first or second treatment. To join, you need to be at least 18 years old, have a life expectancy of at least 3 months, and be willing to provide tissue and blood samples. This is an observational study, meaning you'll receive your usual care, and the study will collect data on how well the ADCs work.

Study design
This is an observational study that will follow 100 participants receiving ADC treatments as part of their routine care. It is not a randomized or blinded study.
What's involved
You would provide blood samples during regular clinical visits and allow researchers to review your medical records. You will also need to provide an archival tissue sample.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure progression-free survival. After the last ADC dose, survival data will be collected via chart review every 12 weeks for up to 2 years.

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NCT06774027

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

Recruiting
Not specifiedAges 18+Observational
University of California, San Francisco
~100 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Specimen collectionNon-Investigational Antibody-Drug Conjugates (ADC)Medical Record Review

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Real-world progression free survival (rwPFS) of first line ADC (ADC1)
Measured over Up to 5 years
+1 more outcome measured

Conditions

HER2-negative Breast Cancer
HER2 Negative Breast Carcinoma
Metastatic Breast Cancer
HR+ HER2 Breast Cancer
Metastatic Triple Negative Breast Cancers
Metastatic Triple-Negative Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Laura Huppert, MD,BA · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Amy Langdon
[email protected]
(415) 353-7288
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Real-world progression free survival (rwPFS) of first line ADC (ADC1)Up to 5 years

    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)Up to 5 years

    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).