61
Participants
Start Date
June 30, 2011
Primary Completion Date
June 30, 2022
Study Completion Date
June 30, 2022
Carboplatin/Paclitaxel
Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
Trastuzumab
Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
Montefiore Medical Center, The Bronx
Holy Cross Hospital, Silver Spring
University of Maryland Medical Center, Silver Spring
Greater Baltimore Medical Center, Baltimore
University of Virginia, Charlottesville
Duke University School of Medicine, Durham
The Ohio State University, Hilliard
Cleveland Clinic, Cleveland
The University of Chicago Medicine, Chicago
Penrose St. Francis Hospital, Colorado Springs
St. Joseph's Hospital and Medical Center, Phoenix
University of Arizona Cancer Center, Tucson
Women's Cancer Research Foundation, Newport Beach
John Muir Clinical Research Center, Concord
Danbury Hospital, Danbury
University of Connecticut Health Center, Farmington
The Hospital of Central Connecticut, New Britain
Smilow Cancer Hospital at Yale New Haven, New Haven
Walter Reed National Military Medical Center, Bethesda
Jersey Shore University Medical Center, Neptune City
Collaborators (1)
Genentech, Inc.
INDUSTRY
Yale University
OTHER