Recruiting

Antibody-Drug Conjugates

Sponsor:

UCLA

Code:

NCT06774027

Conditions

HER2-negative Breast Cancer

HER2 Negative Breast Carcinoma

Metastatic Breast Cancer

HR+ HER2 Breast Cancer

Metastatic Triple Negative Breast Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Specimen collection

Non-Investigational Antibody-Drug Conjugates (ADC)

Medical Record Review

Study Details

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.

Conditions

HER2-negative Breast Cancer

HER2 Negative Breast Carcinoma

Metastatic Breast Cancer

HR+ HER2 Breast Cancer

Metastatic Triple Negative Breast Cancers

Study ID

NCT06774027

Start date

Oct 8, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Specimen collection

Blood specimens will be collected during regular clinical visits for correlative and exploratory analysis

Non-Investigational Antibody-Drug Conjugates (ADC)

ADC given under usual care for the treatment of cancer

Medical Record Review

Prospective and retrospective medical chart reviews will be conducted to obtain data for analysis.

Primary outcome measure

  • Real-world progression free survival (rwPFS) of first line ADC (ADC1) [ Time Frame: Up to 5 years ]
  • rwPFS of second line ADC (ADC2) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Laura Huppert, MD, BA

More Information

Sponsor

University of California, San Francisco

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-12-18.