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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 is a Phase 3 study that has completed, run by Puma Biotechnology. The registered enrollment target is 621 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01808573
The ClinicalTrials.gov registry entry for NCT01808573 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 621 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which capecitabine is the first listed.
NCT01808573 reports 0 study locations.
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.
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