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

NCT06774027 | Recruiting

• 2 other identifiers: 247516TBCRC 067
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Real-world progression free survival (rwPFS) of first line ADC (ADC1)

  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).

  Up to 5 years

• rwPFS of second line ADC (ADC2)

  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).

  Up to 5 years

Secondary Outcomes (6)

• Median Duration of Response (DOR)

  Up to 5 years

• Best Overall Response (BOR)

  Up to 5 years

• Overall Response Rate (ORR)

  Up to 5 years

• Disease Control Rate (DCR)

  Up to 5 years

• Median Real-World Overall Survival Rate (rwOS)

  Up to 5 years

Study Arms (4)

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.

Procedure: Specimen collection; Drug: Non-Investigational Antibody-Drug Conjugates (ADC); Other: Medical Record Review

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.

Procedure: Specimen collection; Drug: Non-Investigational Antibody-Drug Conjugates (ADC); Other: Medical Record Review

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.

Procedure: Specimen collection; Drug: Non-Investigational Antibody-Drug Conjugates (ADC); Other: Medical Record Review

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.

Procedure: Specimen collection; Drug: Non-Investigational Antibody-Drug Conjugates (ADC); Other: Medical Record Review

Interventions

Non-Investigational Antibody-Drug Conjugates (ADC) DRUG

ADC given under usual care for the treatment of cancer

Also known as: Non-Investigational ADC

Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1)); Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1; Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2)); Cohort 4: mTNBC participants enrolled before ADC2

Specimen collection PROCEDURE

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

Also known as: Biospecimen collection

Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1)); Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1; Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2)); Cohort 4: mTNBC participants enrolled before ADC2

Medical Record Review OTHER

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

Also known as: Medical Chart Review

Cohort 1: HR+/HER2- mBC participants enrolled before first line ADC (ADC1)); Cohort 2: Metastatic Triple Negative Breast Cancer (mTNBC) participants enrolled before ADC1; Cohort 3: HR+/HER2- mBC Participants enrolled before second line ADC (ADC2)); Cohort 4: mTNBC participants enrolled before ADC2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults receiving routine treatment for metastatic breast cancer who have planned, usual care with first line or second line of ADC.

You may qualify if:

• Male or female patients aged 18 years or greater with ability to provide written informed consent for this prospective registry study.
• Estimated life expectancy of at least at 3 months per investigator assessment.
• Willingness to provide an archival tissue sample and blood samples (20cc research blood collection at several timepoints) for research purposes.
• 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.

You may not qualify if:

• 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.
• Current participation in a clinical trial with an ADC.
• Contraindication to research phlebotomy to collect \~20cc blood at each research blood draw timepoint.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Translational Breast Cancer Research Consortium: collaborator
• Gilead Sciences: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be collected during routine clinic visits

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Laura Huppert, MD,BA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Langdon

CONTACT

(415) 353-7288; Amy.Deluca@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)