Overview

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Status:
NOT_YET_RECRUITING
Trial end date:
2028-06-02
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
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
Treatments:
abemaciclib
Androgen Antagonists
Capecitabine
Everolimus