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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06774027
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Specimen collection — PROCEDURE
    Blood specimens will be collected during regular clinical visits for correlative and exploratory analysis
  • Non-Investigational Antibody-Drug Conjugates (ADC) — DRUG
    ADC given under usual care for the treatment of cancer
  • Medical Record Review — OTHER
    Prospective and retrospective medical chart reviews will be conducted to obtain data for analysis.

Study Details

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.

Key Dates

Start date
Oct 8, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1))
    Participants with histologically documented HR+/HER2- MBC with a plan to start an FDA-approved ADC as a first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
  • Arm: Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1
    Participants with histologically documented metastatic TNBC with a plan to start an FDA-approved ADC as their first ADC per usual care will be enrolled before beginning any ADC. Participants will have blood samples obtained during routine clinical visits during ADC1 and ADC2, if applicable.
  • Arm: Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2))
    Participants with histologically documented HR+/HER2- MBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual 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. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.
  • Arm: Cohort 4: mTNBC participants enrolled before ADC2
    Participants with histologically documented metastatic TNBC with plan to start an FDA-approved ADC as their second ADC per usual care (ADC1 should be an approved ADC administered per usual 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. Participants will have blood samples obtained during routine clinical visits during treatment of cancer with ADC2.

Primary Outcome Measure

Real-world progression free survival (rwPFS) of first line ADC (ADC1) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Amy Langdon
[email protected]
415-353-7288
[email protected]
877-827-3222
Laura Huppert, MD, BA (PRINCIPAL_INVESTIGATOR)
Leif Ellison, MD, PhD (SUB_INVESTIGATOR)

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By condition
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By specialty
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By research site
University of California, San Francisco· San Francisco, CA

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