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NCT07454668 · ClinicalTrials.gov registry record · Phase 1
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
A Phase 1 study, sponsored by Baptist Health South Florida.
- Not yet
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07454668: Clinical Trial Phase 1 study, sponsored by Baptist Health South Florida.
NCT07454668 is a Phase 1 study that has not yet begun recruiting, run by Baptist Health South Florida. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07454668, a Phase 1 study, has not yet begun recruiting, sponsored by Baptist Health South Florida.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotactic radiosurgery (SRS) when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd). The combined use of SRS with T-DXd is considered investigational.
Primary Outcome
DLTs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 starting from the first dose of T-DXd through 3 weeks after SRS. DLT is defined as the appearance of side effects during treatment that are severe enough to prevent continuation of treatment at a participant's assigned dose. Any of the following events will be considered a DLT if treatment-related: * ≥ Grade 4 non-hematologic toxicity except nausea and vomiting (if manageable with supportive care measures),
Interventions
- RADIATION Stereotactic Radiosurgery
- DRUG Trastuzumab Deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
What is known before NCT07454668 opens enrollment
NCT07454668 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Stereotactic Radiosurgery is the first listed.
NCT07454668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07454668 about?
NCT07454668 is a clinical study titled "Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases". A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotac...
What is the current status of trial NCT07454668?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-06. Estimated completion is 2029-07.
What interventions are being tested in trial NCT07454668?
The interventions under investigation include: Stereotactic Radiosurgery (RADIATION), Trastuzumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT07454668?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07454668's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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