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NCT00398567 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
A Phase 1 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT00398567: Completed Phase 1 study, sponsored by Puma Biotechnology.
NCT00398567 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398567, a Phase 1 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.
Primary Outcome
16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population.
Interventions
- DRUG trastuzumab
- DRUG HKI-272
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2007-04-04 |
| Est. Completion | 2018-03-02 |
| Phase | Phase 1 |
What the finished NCT00398567 record still lists
NCT00398567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.
NCT00398567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00398567 about?
NCT00398567 is a clinical study titled "A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer". The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.
What is the current status of trial NCT00398567?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2007-04-04. Estimated completion is 2018-03-02.
What interventions are being tested in trial NCT00398567?
The interventions under investigation include: trastuzumab (DRUG), HKI-272 (DRUG).
Who is sponsoring clinical trial NCT00398567?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00398567's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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