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Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
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.
Official title: TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2026-02
Completion Date
2031-06-02
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
SERD* + abemaciclib
Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
SERD* + everolimus
Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.
SERD* + everolimus or capecitabine
Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.
SOC
standard-of-care (SOC) chemotherapy in breast cancer
Antiandrogen
Antiandrogen therapy
Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States