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NCT07458113 · ClinicalTrials.gov registry record · Phase 2
Sac-TMT for Active TNBC Brain Metastases
A Phase 2 study, sponsored by Yale University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT07458113: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT07458113 is a Phase 2 study that has not yet begun recruiting, run by Yale University. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07458113, a Phase 2 study, has not yet begun recruiting, sponsored by Yale University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death.
Primary Outcome
To determine the intracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. RANO-BM evaluates treatment response by categorizing results into Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Interventions
- DRUG Sacituzumab tirumotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-05 |
| Est. Completion | 2029-05 |
| Phase | Phase 2 |
What is known before NCT07458113 opens enrollment
NCT07458113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Sacituzumab tirumotecan is the first listed.
NCT07458113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07458113 about?
NCT07458113 is a clinical study titled "Sac-TMT for Active TNBC Brain Metastases". This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, c...
What is the current status of trial NCT07458113?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-05. Estimated completion is 2029-05.
What interventions are being tested in trial NCT07458113?
The interventions under investigation include: Sacituzumab tirumotecan (DRUG).
Who is sponsoring clinical trial NCT07458113?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07458113's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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