A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2 Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer
Both
Breast Cancer
Trial Information
A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2 Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented breast cancer
- Metastatic or unresectable locally advanced/recurrent breast cancer
- HER2-positive disease by prospective laboratory confirmation
- Disease progression on the last regimen received as defined by the investigator
- Prior treatment with an trastuzumab, a taxane, and lapatinib
- Disease progression after at least two regimens of HER2-directed therapy in the
metastatic or unresectable locally advanced/recurrent setting
- Adequate organ function, as evidenced by laboratory results
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- LVEF >/= 50% by ECHO or MUGA
Exclusion Criteria:
- Chemotherapy
- Trastuzumab
- Lapatinib
- Prior enrolment in a T-DM1 containing study, regardless whether the patient received
prior T-DM1
- Brain metastases that are untreated or symptomatic, or require any radiation, surgery
or corticosteroid therapy to control symptoms within 1 month of randomization
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival by investigator assessment according to RECIST
Outcome Time Frame:
approximately 2 years
Safety Issue:
No
Principal Investigator
Melanie Smitt, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
TDM4997g
NCT ID:
NCT01419197
Start Date:
September 2011
Completion Date:
June 2015
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| 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 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Kansas City, Kansas 66160 | |
| Scarborough, Maine 04074 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Wilmington, Delaware | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Washington, District of Columbia | |
| Coeur D'alene, Idaho 83814 |
