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NCT01808573 · ClinicalTrials.gov registry record · Phase 3
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
A Phase 3 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 3
- Development phase
- 621
- Enrollment target
NCT01808573: Completed Phase 3 study, sponsored by Puma Biotechnology.
NCT01808573 is a Phase 3 study that has completed, run by Puma Biotechnology. The registered enrollment target is 621 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01808573, a Phase 3 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 621 participants
- Enrollment target
Study Summary
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
Primary Outcome
Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tum
Interventions
- DRUG capecitabine
- DRUG lapatinib
- DRUG neratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 621 participants |
| Start Date | 2013-03-29 |
| Est. Completion | 2019-12-09 |
| Phase | Phase 3 |
What the finished NCT01808573 record still lists
NCT01808573 is an interventional study that assigns participants to a tested intervention. The registered 621 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which capecitabine is the first listed.
NCT01808573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01808573 about?
NCT01808573 is a clinical study titled "A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting". This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the meta...
What is the current status of trial NCT01808573?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 621 participants. The study started on 2013-03-29. Estimated completion is 2019-12-09.
What interventions are being tested in trial NCT01808573?
The interventions under investigation include: capecitabine (DRUG), lapatinib (DRUG), neratinib (DRUG).
Who is sponsoring clinical trial NCT01808573?
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 NCT01808573's enrollment target sits among peer trials
621 588th of 2000 higher than 1,412 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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