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NCT05553522 · ClinicalTrials.gov registry record · Phase 1
Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer
A Phase 1 study, sponsored by Baptist Health South Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT05553522: Clinical Trial Phase 1 study, sponsored by Baptist Health South Florida.
NCT05553522 is a Phase 1 study that was terminated before completion, run by Baptist Health South Florida. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05553522, a Phase 1 study, was terminated before completion, sponsored by Baptist Health South Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab. The combined use of SRS with the three drugs is considered investigational.
Primary Outcome
Toxicities will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). DLTs are defined as any of the following events: 1. Grade 3 or 4 thrombocytopenia 2. Grade 4 anemia 3. Grade 4 neutropenia lasting more than 7 days 4. Febrile neutropenia 5. Any non-hematologic toxicity of grade 3 or greater (excluding alopecia) despite maximal medical therapy 6. Grade 4 radiation-induced skin changes 7. Any episode of noninfectious pne
Interventions
- COMBINATION_PRODUCT Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2025-12-17 |
| Phase | Phase 1 |
Why NCT05553522 stopped before completion
NCT05553522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine is the first listed.
NCT05553522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05553522 about?
NCT05553522 is a clinical study titled "Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer". This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab. The combined use of SR...
What is the current status of trial NCT05553522?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2024-01-29. Estimated completion is 2025-12-17.
What interventions are being tested in trial NCT05553522?
The interventions under investigation include: Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05553522?
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 NCT05553522's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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