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NCT03289039 · ClinicalTrials.gov registry record · Phase 2
Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03289039: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT03289039 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03289039, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: * Neratinib and Fulvestrant * Neratinib alone
Primary Outcome
Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. D
Interventions
- DRUG Neratinib
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-10-25 |
| Est. Completion | 2021-07-20 |
| Phase | Phase 2 |
Why NCT03289039 stopped before completion
NCT03289039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.
NCT03289039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03289039 about?
NCT03289039 is a clinical study titled "Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer". This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: * Neratinib and Fulvestrant * Neratinib alone
What is the current status of trial NCT03289039?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2017-10-25. Estimated completion is 2021-07-20.
What interventions are being tested in trial NCT03289039?
The interventions under investigation include: Neratinib (DRUG), Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT03289039?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03289039's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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