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 Da

Trial Details

NCT ID
NCT07340541
Phase
PHASE2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • SERD* + abemaciclib
  • SERD* + everolimus
  • SERD* + everolimus or capecitabine
  • SOC
  • Antiandrogen
Locations (sample)
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility 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).

For full eligibility, visit ClinicalTrials.gov.

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