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NCT00300781 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
A Phase 2 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
NCT00300781: Completed Phase 2 study, sponsored by Puma Biotechnology.
NCT00300781 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00300781, a Phase 2 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
Primary Outcome
16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
Interventions
- DRUG neratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2006-08-04 |
| Est. Completion | 2018-01-30 |
| Phase | Phase 2 |
What the finished NCT00300781 record still lists
NCT00300781 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which neratinib is the first listed.
NCT00300781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00300781 about?
NCT00300781 is a clinical study titled "Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer". The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
What is the current status of trial NCT00300781?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2006-08-04. Estimated completion is 2018-01-30.
What interventions are being tested in trial NCT00300781?
The interventions under investigation include: neratinib (DRUG).
Who is sponsoring clinical trial NCT00300781?
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 NCT00300781's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 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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