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NCT00777101 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
A Phase 2 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 233
- Enrollment target
NCT00777101: Completed Phase 2 study, sponsored by Puma Biotechnology.
NCT00777101 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 233 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00777101, a Phase 2 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 233 participants
- Enrollment target
Study Summary
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.
Primary Outcome
Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
Interventions
- DRUG Capecitabine
- DRUG Neratinib
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2009-02-04 |
| Est. Completion | 2018-06-03 |
| Phase | Phase 2 |
What the finished NCT00777101 record still lists
NCT00777101 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT00777101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00777101 about?
NCT00777101 is a clinical study titled "Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer". This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of ...
What is the current status of trial NCT00777101?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 233 participants. The study started on 2009-02-04. Estimated completion is 2018-06-03.
What interventions are being tested in trial NCT00777101?
The interventions under investigation include: Capecitabine (DRUG), Neratinib (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00777101?
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 NCT00777101's enrollment target sits among peer trials
233 256th of 2000 higher than 1,745 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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