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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: Recruiting Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (426% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-Free Survival (PFS) is defined as the time from initiation of study therapy until documented disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 or death from any cause, whichever occurs first. For intra-individual comparisons across successive therapy lines, a PFS ratio will be calculated by dividing the PFS of the current line (nth line, PFSₙ) by the PFS of the preceding line ((n-1)th line, PFSn-1). This allows each patient to serve as their
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 |
What NCT07340541 shows while recruiting
NCT07340541 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (426% higher).
The record links to 0 conditions, and to 5 interventions - of which SOC is the first listed.
NCT07340541 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07340541's enrollment target sits among peer trials
700 46th of 2000 higher than 1,955 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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