NCT07340541RecruitingPhase 2
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 16 Feb 2026
- Primary completion date
- 2 Jun 2031
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- NCT number
- NCT07340541
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 700
- From 16 Feb 2026 to the primary completion date, 2 Jun 2031
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Inaccessible metastatic lesion to research biopsy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Yale Cancer Center/Clinical Trials Office Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.