NCT07340541 Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
| NCT ID | NCT07340541 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2031-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 700 participants in total. It began in 2026-02-16 with a primary completion date of 2031-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Lisa A Carey, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07340541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07340541 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07340541 currently recruiting?
Yes, NCT07340541 is actively recruiting participants. Contact the research team at emily_lane@med.unc.edu for enrollment information.
Where is the NCT07340541 trial being conducted?
This trial is being conducted at Rochester, United States, Chapel Hill, United States.
Who is sponsoring the NCT07340541 clinical trial?
NCT07340541 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Lisa A Carey, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 700 participants.
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