A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Invasive disease-free survival (IDFS): Time from randomization to ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death of any cause
up to 10 years
No
Clinical Trials
Study Director
Hoffmann-La Roche
United States: Food and Drug Administration
BO27938
NCT01772472
April 2013
March 2023
Name | Location |
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Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
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 | |
Scarborough, Maine 04074 | |
Hackensack, New Jersey 07601 | |
Anchorage, Alaska | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Charleston, South Carolina | |
Washington, District of Columbia | |
Las Vegas, Nevada 89109 | |
Sioux Falls, South Dakota | |
Bismarck, North Dakota 58501 |