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NCT07340541 · ClinicalTrials.gov registry record · Phase 2
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
NCT07340541 is a Phase 2 study that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 700 participants.
The verdict
NCT07340541, a Phase 2 study, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
Study 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.
Interventions
- DRUG SOC
- DRUG SERD* + abemaciclib
- DRUG SERD* + everolimus
- DRUG SERD* + everolimus or capecitabine
- DRUG Antiandrogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2026-02-16 |
| Est. Completion | 2031-06-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07340541
The ClinicalTrials.gov registry entry for NCT07340541 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which SOC is the first listed.
NCT07340541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07340541 about?
NCT07340541 is a clinical study titled "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 prospect...
What is the current status of trial NCT07340541?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2026-02-16. Estimated completion is 2031-06-02.
What interventions are being tested in trial NCT07340541?
The interventions under investigation include: SOC (DRUG), SERD* + abemaciclib (DRUG), SERD* + everolimus (DRUG), SERD* + everolimus or capecitabine (DRUG), Antiandrogen (DRUG).
Who is sponsoring clinical trial NCT07340541?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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