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NCT03094052 · ClinicalTrials.gov registry record · Phase 2
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT03094052: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT03094052 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03094052, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.
Primary Outcome
Percentage of participants with clinically assessed grade 3 or greater diarrhea reported within the first 2 cycles (each cycle is 21 days) of neratinib while using anti-diarrheal strategies. Reports of diarrhea will be graded according to NCI CTCAE version 4.0.
Interventions
- DRUG Neratinib
- BIOLOGICAL Trastuzumab
- DRUG Loperamide
- DRUG Crofelemer
- DRUG Diphenoxylate/Atropine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 2 |
What the finished NCT03094052 record still lists
NCT03094052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Neratinib is the first listed.
NCT03094052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03094052 about?
NCT03094052 is a clinical study titled "Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib". This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells,...
What is the current status of trial NCT03094052?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2018-10-09. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT03094052?
The interventions under investigation include: Neratinib (DRUG), Trastuzumab (BIOLOGICAL), Loperamide (DRUG), Crofelemer (DRUG), Diphenoxylate/Atropine (DRUG).
Who is sponsoring clinical trial NCT03094052?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03094052's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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