HKI-272 for HER2-Positive Breast Cancer and Brain Metastases
Public ClinicalTrials.gov record NCT01494662. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial of HKI-272 (Neratinib), Neratinib and Capecitabine, and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01494662
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Interventions
- HKI-272 Drug
- Surgical Resection Procedure
- Capecitabine Drug
- Ado-Trastuzumab Emtansine Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2012 (Actual)
- Primary completion
- Feb 1, 2023 (Actual)
- Completion
- Apr 19, 2024 (Actual)
- Last update posted
- Jan 23, 2026
2012 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco Medical Center | San Francisco | California | 94115 | — |
| MedStar Georgetown Univeristy Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Massachusetts General Hosptial | Boston | Massachusetts | 02215 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| UPMC Passavant Cranberry | Cranberry Township | Pennsylvania | 16066 | — |
| Arnold Palmer Cancer Center-Greensburg | Greensburg | Pennsylvania | 15601 | — |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17101 | — |
| UPMC Ortenzio Cancer Center | Mechanicsburg | Pennsylvania | 17050 | — |
| UPMC Cancer Centers - Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Baylor College of Medicine Lester and Sue Smith Breast Center | Houston | Texas | 77030 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01494662, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 23, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01494662 live on ClinicalTrials.gov.