Actively Recruiting
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-13
700
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
A
Advanced Research Projects Agency for Health (ARPA-H)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
- Willing and able to comply with study procedures as judged by the investigator
- Age 18 years or older at the time of consent
- ECOG Performance Status of 0 to 2
- Fulfilled all eligibility criteria and consented to the LCCC2521 Parent Protocol
You will not qualify if you...
- Metastatic lesion inaccessible to research biopsy
- Already started second-line therapy
- Concurrent disease or condition making the patient unsuitable for study participation according to the treating oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7305
Actively Recruiting
Research Team
E
Emily L Schworer
CONTACT
A
Ana Gallegos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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