clinical trial · NCT06774027

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

University of California, San Francisco·—·recruiting·n = 100

HER2-negative Breast CancerHER2 Negative Breast CarcinomaMetastatic Breast CancerHR+ HER2 Breast CancerMetastatic Triple Negative Breast CancersMetastatic Triple-Negative Breast CarcinomaSpecimen collectionNon-Investigational Antibody-Drug Conjugates (ADC)Medical Record Review

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.

started

Oct 8, 2025

primary completion

Dec 31, 2030

completion

Dec 31, 2030

last updated

Dec 18, 2025

detailed description

PRIMARY OBJECTIVES:

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.

official title

ENCORE: Multicenter ProspectivE Registry of Sequential ANtibody Drug COnjugates (ADCs) in HER2 Negative Metastatic BREast Cancer (MBC)

full record on clinicaltrials.gov ↗

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