A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
- Participants will enroll in this study at the time they are starting their adjuvant
therapy for breast cancer. Participants will receive chemotherapy with paclitaxel
every week for 12 weeks. They will begin to receive trastuzumab at the same time they
begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab,
they will receive trastuzumab every 3 weeks or weekly for 40 weeks.
- Participants will be followed with routine assessments such as physical exam and vital
signs every 3 months for the first year, and then every 6 months for years 2-5. Then
we would like to keep track of the participants medical condition by calling them on
the telephone once per year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate disease free survival (DFS) rate in patients with node-negative HER2-positive breast cancer with tumors less than or equal to 3cm treated with adjuvant trastuzumab and paclitaxel
3 years
No
Eric Winer, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
07-199
NCT00542451
October 2007
December 2013
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of California-San Francisco | San Francisco, California 94143 |
Washington University | St. Louis, Missouri 63110 |
Indiana University | Indianapolis, Indiana 46202 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Weill Cornell Medical College | New York, New York 10021 |
North Shore Medical Center | Salem, Massachusetts 01970 |
Dana-Farber at Faulkner Hospital | Boston, Massachusetts 02130 |
John Hopkins University | Baltimore, Maryland 21231 |
Cape Cod Healthcare | Hyannis, Massachusetts 02601 |
Lowelll General Hospital | Lowell, Massachusetts 01854 |
North Shore LIJ Health System Monter Cancer Center | Lake Success, New York 11042 |
Case Western University | Cleveland, Ohio 44195 |
Tennesse Oncology | Nashville, Tennessee 37203 |
University of Vermont Cancer Center | Burlington, Vermont 05401 |