A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
Inclusion Criteria:
- Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
- Been treated for early breast cancer with standard of care duration of trastuzumab.
- Could have been treated neoadjuvantly but have not reached pCR.
Exclusion Criteria:
- Positive clinical and radiologic assessments for local or regional recurrence of
disease at the time of study entry.
- History of heart disease.
- QTc interval >0.45 seconds
- History of gastrointestinal disease with diarrhea as the major symptom.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
disease free survival (DFS)
Outcome Time Frame:
Two years
Safety Issue:
No
Principal Investigator
Puma
Investigator Role:
Study Director
Investigator Affiliation:
Biotechnology
Authority:
United States: Food and Drug Administration
Study ID:
3144A2-3004
NCT ID:
NCT00878709
Start Date:
July 2009
Completion Date:
October 2013
Related Keywords:
- Breast Cancer
- HER-2/erbB-2 positive breast cancer
- breast cancer
- adjuvant therapy
- neratinib
- HKI-272
- Breast Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Flagstaff, Arizona 86001 |
| Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Easley,, South Carolina 29640 |
| Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
| Pfizer Investigational Site | Livingston, New Jersey 07039 |
| Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |
| Pfizer Investigational Site | Burlington, Vermont 05401-3456 |
| Pfizer Investigational Site | Salt Lake City, Utah 84112 |
| Pfizer Investigational Site | Billings, Montana 59101 |
| Pfizer Investigational Site | Lewistown, Idaho 83501 |
| Pfizer Investigational Site | Bangor, Maine 04401 |
| Pfizer Investigational Site | Honolulu, Hawaii 96813 |
| Pfizer Investigational Site | Bismarck, North Dakota 58503 |
| Pfizer Investigational Site | Aberdeen, South Dakota 57401 |
| Pfizer Investigational Site | Morgantown, West Virginia 26506 |
| Pfizer Investigational Site | Providence, Rhode Island 02906 |
