Adaptive biomarker-driven therapies for metastatic breast cancer
TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)
This trial tests whether matching targeted drug combinations to tumor biomarkers helps people with ER+/HER2- or triple-negative metastatic breast cancer who are starting second-line treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07340541 on ClinicalTrials.gov |
What this trial studies
This multi-arm, biomarker-stratified platform enrolls patients with ER+/HER2- or triple-negative metastatic breast cancer who have progressed on first-line therapy and are about to start second-line treatment. The design uses both archival tumor tissue and prospective tumor and blood sampling, with liquid biopsies collected before treatment and at each re-staging visit. Patients are assigned to biomarker-directed treatment arms (including combinations with SERDs, CDK4/6 inhibitors, mTOR inhibitors, capecitabine, or antiandrogens) and may be reassigned to other eligible subtrials upon progression. The primary endpoint for each arm is progression-free survival, and the adaptive framework is intended to accelerate learning and the evaluation of multiple targeted approaches simultaneously.
Who should consider this trial
Good fit: Adults (≥18) with ER+/HER2- or triple-negative metastatic breast cancer who have progressed on first-line therapy, have ECOG 0–2, and can provide required archival tissue and prospective tumor and blood samples prior to second-line therapy are the intended participants.
Not a fit: Patients with HER2-positive disease, those who have already started second-line therapy, or those unable to undergo the required biopsies or follow-up visits are not eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide more personalized second-line treatment options and potentially extend the time patients live without disease progression.
How similar studies have performed: Other biomarker-driven platform and umbrella trials (for example NCI-MATCH and various precision-oncology platforms) have demonstrated that matched therapies can benefit some patients, but results have been mixed and the adaptive multi-arm approach remains an evolving strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lisa A Carey, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Emily L Schworer
- Email: emily_lane@med.unc.edu
- Phone: 919-984-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.