A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab Emtansine vs. Capecitabine + Lapatinib in Patients With HER2-positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-based Therapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS) Assessed by an Independent Review Committee
PFS was defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurred earlier. All measurable lesions up to a maximum of 5 per organ and 10 in total, representative of all involved organs, should be identified as target lesions (TL) and recorded and measured at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs will be calculated and reported as the baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as ≥ 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
No
Clinical Trials
Study Director
Genentech
United States: Food and Drug Administration
TDM4370g
NCT00829166
February 2009
April 2014
Name | Location |
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Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Great Falls, Montana 59405 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Kansas City, Kansas 66160 | |
Scarborough, Maine 04074 | |
Omaha, Nebraska 68114 | |
Hackensack, New Jersey 07601 | |
Albuquerque, New Mexico 87131-5636 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Charleston, South Carolina | |
Providence, Rhode Island 02908 | |
Washington, District of Columbia | |
Las Vegas, Nevada 89109 | |
Coeur D'alene, Idaho 83814 |