Spots Global Cancer Trial Database for A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
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Trial Identification
Brief Title: A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
Official Title: A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer
Study ID: NCT00398567
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.
Detailed Description: Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with IV trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer. Three to six subjects will be enrolled in each dose group. Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21. When the maximum tolerated dose (MTD) of HKI-272 plus trastuzumab is determined, an additional 30 subjects will be enrolled at that dose level, and followed for progression free survival for approximately 1 year.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
City of Hope National Medical Center, Pasadena, California, United States
University of Maryland, University of Maryland Medical Center, Baltimore, Maryland, United States
Duke University, Duke University Medical Center, Durham, North Carolina, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Chinese Nanjing Bayi Hospital, Nanjing, Jiangsu, China
Tianjin Union Medicine Center, Tianjin, Tianjin, China
Cancer Hospital, Academy of Med Science and Peking Union Med, Beijing, , China
307 Hospital of Chinese People's Liberation Army, Beijing, , China
Chinese PLA General Hospital, Beijing, , China
Institut Curie, Paris, , France
Centre Rene Gauducheau, Saint-Herblain, , France
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Contact Details
Name: Puma
Affiliation: Biotechnology
Role: STUDY_DIRECTOR
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