Spots Global Cancer Trial Database for Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
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Trial Identification
Brief Title: Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
Official Title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB ADMINISTERED IN COMBINATION WITH LETROZOLE VS. LETROZOLE ALONE AS FIRST LINE THERAPY IN POST-MENOPAUSAL WOMEN WITH LOCALLY ADVANCED OR METASTATIC ER+/PR+/HER2- BREAST CANCER.
Study ID: NCT00880009
Conditions
Study Description
Brief Summary: This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.
Detailed Description: This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
American Institute of Research, Whittier, California, United States
Joliet Oncology Hematology Associates, Joliet, Illinois, United States
Oncology Specialists SC, Niles, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
AZ Sint-Augustinus, Wilrijk, , Belgium
Cancer Hospital, Academy of Med Science and Peking Union Med, Beijing, Beijing, China
UNIMED Medical Institute, Hong Kong, , Hong Kong
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly, Budapest, , Hungary
Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdr, Warszawa, , Poland
Johns Hopkins Singapore International Medical Centre, Singapore, , Singapore
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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