A Phase Ib/II, Open-Label Study of the Safety, Tolerability, and Efficacy of Trastuzumab-MCC-DM1 in Combination With Pertuzumab Administered Intravenously to Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events or changes in physical findings and clinical laboratory results during and following study drug administration that result in dose modification, dose delay, or discontinuation of T-DM1 and/or pertuzumab
Up to study discontinuation or up to 1 year after the last patient is enrolled
No
Elaine K. Wong, M.Sc., M.D.
Study Director
Genentech
United States: Food and Drug Administration
TDM4373g
NCT00875979
May 2009
January 2012
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Miami, Florida 33176 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Kansas City, Kansas 66160 | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Indianapolis, Indiana |