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Brief Title: Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
Official Title: Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
Study ID: NCT00300781
Brief Summary: The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
Detailed Description: Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Colorado Hospital, Aurora, Colorado, United States
Midwestern Regional Medical Center, Zion, Illinois, United States
Louisiana State University, Shreveport, Louisiana, United States
The Cancer Center at GBMC, Baltimore, Maryland, United States
Oncology Care Associates, Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Boston University Medical Center, Boston, Massachusetts, United States
Faulkner Hospital, Boston, Massachusetts, United States
Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
The Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Institut Jules Bordet Unite du Chimiotherapie, Brussels, , Belgium
University Hospital Gasthuisberg, Leuven, , Belgium
St-Augustinus Ziekenhuis Oncology Department, Wilrijk, , Belgium
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army, Beijing, Beijing, China
No. 81 Hospital of Chinese People's Liberation Army, Nanjing, Jiangsu, China
Cancer Hospital Peking Union Medical College, Beijing, , China
Chinese People's Liberation Army General Hospital, Beijing, , China
Institut Gustave ROUSSY Service de Pathologie Mammaire, Villejuif Cedex, , France
Jehangir Clinical Development Centre, Pune, Maharashtra, India
Deenanath Mangeshkar Hospital, Pune, Maharashtra, India
Nizam's Institute of Medical Sciences, Hyderabad, Panjagutta, India
Tata Memorial Centre, Mumbai, Parel, India
Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica, Mexico City, , Mexico
Arke Estudios Clínicos S.A. de C.V., Mexico City, , Mexico
Hospital de Especialidades MIG, Mexico City, , Mexico
N.N. Blokhin Russian Cancer Research Center of RAMS, Moscow, , Russian Federation
Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods, Obninsk, , Russian Federation
City Oncology Dispensary, Saint Petersburg, , Russian Federation
City Hospital N 31 Oncology Haematology Dept. For Adults, Saint Petersburg, , Russian Federation
Breast Tumor Department, N.N. Petrov Research Institute of Oncology, Saint-Petersburg, , Russian Federation
Name: Puma
Affiliation: Biotechnology
Role: STUDY_DIRECTOR