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NCT01670877 · ClinicalTrials.gov registry record · Phase 2
Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT01670877: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01670877 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01670877, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
Primary Outcome
* Imaging for clinical benefit rate occurred at baseline (for an initial comparison scan) and every 2 cycles (28 day length) thereafter. * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as referen
Interventions
- DRUG Trastuzumab
- DRUG Neratinib
- DRUG Fulvestrant
- PROCEDURE Tumor biopsy
- PROCEDURE Research blood sample
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-12-11 |
| Est. Completion | 2021-03-11 |
| Phase | Phase 2 |
What the finished NCT01670877 record still lists
NCT01670877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01670877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01670877 about?
NCT01670877 is a clinical study titled "Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer". This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
What is the current status of trial NCT01670877?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2012-12-11. Estimated completion is 2021-03-11.
What interventions are being tested in trial NCT01670877?
The interventions under investigation include: Trastuzumab (DRUG), Neratinib (DRUG), Fulvestrant (DRUG), Tumor biopsy (PROCEDURE), Research blood sample (PROCEDURE).
Who is sponsoring clinical trial NCT01670877?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01670877's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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