Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
NCT ID: NCT06774027
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-10-08
2030-12-31
Brief Summary
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Detailed Description
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I. Real-world progression free survival (rwPFS) of the first line of ADC under routine care (ADC1) by investigator assessment II. Real-world progression free survival (rwPFS) of the second line ADC under routine care (ADC2) by investigator assessment
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of ADC1 and ADC2 as measured by duration of response (DOR), best overall response (BOR), disease control rate (DCR), and overall survival (OS) for each ADC.
II. To evaluate key safety parameters for ADC1 and ADC2 by chart review.
EXPLORATORY OBJECTIVES:
I. To evaluate/identify correlative biomarkers (e.g., circulating tumor DNA (ctDNA), circulating tumor cells (CTC), and tissue spatial correlates) of response/resistance to ADCs.
II. To evaluate patient reported outcomes (PROs) for each ADC.
OUTLINE:
Participants will have medical chart reviews and biospecimens collected for the duration of routine care with ADC1 and/or ADC2. After the last dose of ADC2, participants will continue to be followed for survival data collection via chart review every 12 weeks for up to 2 years.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Translational Breast Cancer Research Consortium
OTHER
Gilead Sciences
INDUSTRY
Johns Hopkins University
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Laura Huppert, MD,BA
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Amy Langdon
Role: primary
Role: backup
Other Identifiers
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TBCRC 067
Identifier Type: OTHER
Identifier Source: secondary_id
247516
Identifier Type: -
Identifier Source: org_study_id