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Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Study acronym: EVOLVE-BDT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 4 to 6
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 10 of 12 entries
  2. Study sites: 3 to 4v9
  3. Study sites: 2 to 3v8
  4. Site contacts updated at 1 of 2 sitesv7
  5. Study sites: 1 to 2v6
  6. Recruitment opened
    • Start date changed from estimate of Feb 2026 to Feb 16, 2026
    • Site details revised
    v5
  7. Primary and study completion dates: Jun 2, 2028 to Jun 2, 2031
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 11 to 12
    v4
  8. Start date: Jan 2026 to Feb 2026v3
  9. Re-verified, no change to tracked fieldsv2
  10. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07340541
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
Conditions
(from sponsor)		 Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov