Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

NCT Number	NCT07340541
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: Advanced Research Projects Agency for Health (ARPA-H), Breast Cancer Research Foundation, Translational Breast Cancer Research Consortium
Conditions	Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma
Enrollment	700 participants
Start Date	2026-02-16
Primary Completion	2031-06-02 (estimated)
Study Completion	2031-06-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-31