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NCT03501979 · ClinicalTrials.gov registry record · Phase 2
Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT03501979: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT03501979 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03501979, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.
Primary Outcome
Number of participants alive. A Gehan-like trial design with an interim futility analysis will be used.
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Tucatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-02-20 |
| Est. Completion | 2021-06-22 |
| Phase | Phase 2 |
Why NCT03501979 stopped before completion
NCT03501979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT03501979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03501979 about?
NCT03501979 is a clinical study titled "Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD". A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.
What is the current status of trial NCT03501979?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2019-02-20. Estimated completion is 2021-06-22.
What interventions are being tested in trial NCT03501979?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Tucatinib (DRUG).
Who is sponsoring clinical trial NCT03501979?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03501979's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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