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Phase 2Recruiting

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Sponsored by UNC Lineberger Comprehensive Cancer Center

About this study

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.

The platform design makes it easy to assess multiple targeted therapies at the same time, focusing on patient groups identified by specific biomarkers. Patients who experience disease progression may be reassigned to additional eligible sub trials evaluating alternative therapeutic options. The primary endpoint for each arm is progression-free survival (PFS). This adaptive framework enables continuous learning and rapid translation of biomarker discoveries into therapeutic evaluation, promoting an agile and data-driven approach to treatment optimization in advanced breast cancer. Beyond ER and HER2, there are few biomarkers to drive treatment decisions in metastatic and primary breast cancer, leaving a gap in effective treatments for other subtypes. To address this, triple-negative (TNBC)…

Where this study is enrolling (6)

  • Yale Cancer Center Clinical Trials Office

    New Haven, Connecticut

    I'm interested

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland

    I'm interested

  • Mayo Clinic

    Rochester, Minnesota

    I'm interested

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina

    Call 919-966-4431

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  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania

    I'm interested
Show all 6 locations
Who can participate

Inclusion criteria

  • ✓Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • ✓Subject is willing and able to comply with study procedures based on the judgement of the investigator.
  • ✓Age ≥ 18 years of age at the time of consent
  • ✓ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).
  • ✓Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol

Exclusion criteria

  • ✕Inaccessible metastatic lesion to research biopsy
  • ✕Subject has already initiated 2nd line therapy
  • ✕Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.