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NCT00878709 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
A Phase 3 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,840
- Enrollment target
NCT00878709: Completed Phase 3 study, sponsored by Puma Biotechnology.
NCT00878709 is a Phase 3 study that has completed, run by Puma Biotechnology. The registered enrollment target is 2,840 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (268% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00878709, a Phase 3 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,840 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Primary Outcome
Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Interventions
- OTHER placebo
- DRUG neratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,840 participants |
| Start Date | 2009-07-09 |
| Est. Completion | 2019-10-04 |
| Phase | Phase 3 |
What the finished NCT00878709 record still lists
NCT00878709 is an interventional study that assigns participants to a tested intervention. Its 2,840 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (268% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00878709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00878709 about?
NCT00878709 is a clinical study titled "Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer". The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
What is the current status of trial NCT00878709?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,840 participants. The study started on 2009-07-09. Estimated completion is 2019-10-04.
What interventions are being tested in trial NCT00878709?
The interventions under investigation include: placebo (OTHER), neratinib (DRUG).
Who is sponsoring clinical trial NCT00878709?
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 NCT00878709's enrollment target sits among peer trials
2,840 81st of 2000 higher than 1,920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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