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NCT02400476 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
A Phase 2 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 563
- Enrollment target
NCT02400476: Completed Phase 2 study, sponsored by Puma Biotechnology.
NCT02400476 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 563 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02400476, a Phase 2 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 563 participants
- Enrollment target
Study Summary
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.
Primary Outcome
The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: L
Interventions
- DRUG Neratinib
- DRUG Budesonide
- DRUG Loperamide
- DRUG Colestipol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 563 participants |
| Start Date | 2015-02 |
| Est. Completion | 2021-04-22 |
| Phase | Phase 2 |
What the finished NCT02400476 record still lists
NCT02400476 is an interventional study that assigns participants to a tested intervention. The registered 563 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 (323% higher).
The record links to 0 conditions, and to 4 interventions - of which Neratinib is the first listed.
NCT02400476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02400476 about?
NCT02400476 is a clinical study titled "An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide". An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.
What is the current status of trial NCT02400476?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 563 participants. The study started on 2015-02. Estimated completion is 2021-04-22.
What interventions are being tested in trial NCT02400476?
The interventions under investigation include: Neratinib (DRUG), Budesonide (DRUG), Loperamide (DRUG), Colestipol (DRUG).
Who is sponsoring clinical trial NCT02400476?
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 NCT02400476's enrollment target sits among peer trials
563 60th of 2000 higher than 1,941 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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