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NCT01494662 · ClinicalTrials.gov registry record · Phase 2
HKI-272 for HER2-Positive Breast Cancer and Brain Metastases
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT01494662: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01494662 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01494662, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.
Primary Outcome
Defined as the percentage of patients achieving a complete response (CR) or partial response (PR) of Central Nervous System (CNS) lesions based on composite criteria, reported separately in Cohorts 1, 3A, 3B. For the volumetric criteria, an objective CR will be defined as the following: Disappearance of all CNS target and non-target lesions sustained for at least 4 weeks; no new lesions; stable or decreasing steroid dose; stable or improved neurological symptoms. An objective PR by volumetric cr
Interventions
- DRUG Capecitabine
- PROCEDURE Surgical Resection
- DRUG Ado-Trastuzumab Emtansine
- DRUG HKI-272
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-02 |
| Est. Completion | 2024-04-19 |
| Phase | Phase 2 |
What the finished NCT01494662 record still lists
NCT01494662 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Capecitabine is the first listed.
NCT01494662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01494662 about?
NCT01494662 is a clinical study titled "HKI-272 for HER2-Positive Breast Cancer and Brain Metastases". The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that ...
What is the current status of trial NCT01494662?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2012-02. Estimated completion is 2024-04-19.
What interventions are being tested in trial NCT01494662?
The interventions under investigation include: Capecitabine (DRUG), Surgical Resection (PROCEDURE), Ado-Trastuzumab Emtansine (DRUG), HKI-272 (DRUG).
Who is sponsoring clinical trial NCT01494662?
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 NCT01494662's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 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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