A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer
OBJECTIVES:
- Compare the disease-free survival and overall survival in patients with node-positive
or high-risk node-negative operable stage II or IIIA breast cancer treated with
docetaxel or paclitaxel after doxorubicin and cyclophosphamide.
- Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks
improves disease-free survival and overall survival when compared with the conventional
schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this
patient population.
- Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12
weeks versus every 3 weeks for 4 courses in these patients.
- Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly
for 12 weeks to that of docetaxel administered on the same schedules in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes
vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no
more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs
breast conservation surgery). Patients are randomized to one of four treatment arms.
- Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4
courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours
every 3 weeks for 4 courses.
- Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.
- Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.
- Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.
Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone
receptor positive tumors receive oral tamoxifen daily for 5 years.
After completion of all chemotherapy, patients with prior segmental mastectomy receive
radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical
mastectomy may receive radiotherapy after chemotherapy completion at the investigator's
discretion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27
years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Joseph A. Sparano, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Food and Drug Administration
CDR0000067353
NCT00004125
October 1999
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Schneider Children's Hospital at North Shore | Manhasset, New York 11030 |