A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery For Node Positive Or High Risk Node Negative Breast Cancer
- Compare the disease-free survival of premenopausal or early postmenopausal women with
previously resected node positive or high-risk node negative stage I-IIIB breast cancer
treated with cyclophosphamide, epirubicin, and fluorouracil vs cyclophosphamide,
epirubicin, filgrastim (G-CSF), and epoetin alfa followed by paclitaxel vs
cyclophosphamide and doxorubicin followed by paclitaxel.
- Compare the overall survival of patients treated with these regimens.
- Compare the rate of toxic effects of these regimens in this patient population.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of positive nodes (0 vs 1-3 vs 4-10 vs more than 10), type of prior surgery (total vs
partial mastectomy), and estrogen receptor status (positive vs negative). Patients are
randomized to one of three treatment arms.
- Arm I: Patients receive epirubicin IV and fluorouracil IV on days 1-8 and oral
cyclophosphamide on days 1-14. Treatment repeats every 28 days for 6 courses.
- Arm II: Patients receive epirubicin IV and cyclophosphamide IV on day 1 and filgrastim
(G-CSF) subcutaneously (SC) on days 2-13. Patients with a hemoglobin < 13.0 g/dL also
receive epoetin alfa SC once weekly beginning within 1 week after the start of therapy
and continuing as needed. Treatment repeats every 14 days for 6 courses. Beginning 21
days after completion of epirubicin and cyclophosphamide, patients receive paclitaxel
IV over 3 hours on day 1 and G-CSF and epoetin alfa as above. Treatment repeats every
21 days for 4 courses.
- Arm III: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over
15 minutes on day 1. Treatment repeats every 21 days for 4 courses.
Beginning 21 days after completion of doxorubicin and cyclophosphamide, patients receive
paclitaxel as in arm II. Treatment in all arms continues in the absence of disease
progression or unacceptable toxicity.
All receptor positive patients receive oral tamoxifen or anastrozole (if tamoxifen is
contraindicated) for 5 years after completion of chemotherapy.
Quality of life is assessed at baseline, day 1 of cycles 2, 3 4 and 6 (arm I), days 1 of
cycles 3 and and day 1 of cycles 1 and 4 of paclitaxel (arm II), day 1 of cycles 2 and 3,
day 1 of cycles 1 and 4 of paclitaxel, (arm III), 9 months, 12 months, and then annually
thereafter until 5 years
Patients are followed at 9 months, 12 months, every 4 months for 1 year, every 6 months for
3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,100 patients (700 per treatment arm) will be accrued for
this study within 4 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival
Mark N. Levine, MD
Margaret and Charles Juravinski Cancer Centre
Canada: Health Canada
|Staten Island University Hospital||Staten Island, New York 10305|
|Our Lady of Mercy Medical Center||Bronx, New York 10466|
|Oncology/Hematology Care, Inc.||Cincinnati, Ohio 45219|
|Maine Center for Cancer Medicine and Blood Disorders||Scarborough, Maine 04074|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|Florida Oncology Associates||Orange Park, Florida 32073|
|Duke University Medical Center||Durham, North Carolina 27710|
|Queens Medical Associates, PC||Fresh Meadows, New York 11365|
|Sparks-Arkansas Oklahoma Cancer Treatment Centre||Fort Smith, Arkansas 72901|
|Hematology Oncology Services of Arkansas||Little Rock, Arkansas 72205|
|Scripps Cancer Center||La Jolla, California 92037|
|University of Colorado Cancer Centre||Aurora, Colorado 80010-0510|
|Greenwich Hospital - Bendheim Cancer Center||Greenwich, Connecticut 06830|
|Sibley Memorial Hospital, Oncology Research||Washington, District of Columbia 20016|
|Comprehensive Cancer Care Centre at Boca Raton||Boca Raton, Florida 33428|
|University of Florida||Gainesville, Florida 32610-0277|
|The University of Chicago Medical Center||Chicago, Illinois 60637-1470|
|Therapy Associates, Inc., Hematology/Oncology||Evansville, Indiana 47715|
|Lexington Oncology Assts./Central Baptist Hospital||Lexington, Kentucky 40503|
|CHRISTUS Schumpert Medical Center - Hem/Onc Clinic||Shreveport, Louisiana 71101|
|Willis-Knighton Cancer Center||Shreveport, Louisiana 71103-3|
|Maine General Medical Center||Waterville, Maine 04901|
|Suburban Hospital Cancer Program||Bethesda, Maryland 20817|
|Associates in Oncology/Hematology||Rockville, Maryland 20850|
|Saint Joseph Medical Center, Cancer Care Program||Towson, Maryland 21204|
|Baystate Regional Cancer Program||Springfield, Massachusetts 01107|
|St. Luke's Cancer Care Centre||Duluth, Minnesota 55802|
|University of Minnesota Cancer Centre||Minneapolis, Minnesota 55455|
|Columbia-Capitol Comprehensive Care Clinics||Jefferson City, Missouri 65109|
|Saint Louis University Hospital||St. Louis, Missouri 63110-0250|
|Creighton University Cancer Centre||Omaha, Nebraska 68131|
|Nebraska Methodist Hospital||Omaha, Nebraska 68114|
|Advanced Oncology Associates||Armonk, New York 10504|
|Winthrop University Hospital Onc/Hem||Mineola, New York 11501|
|Hematology Oncol. Associates Rockland||Nyack, New York 10960|
|University of Rochester||Rochester, New York 14642|
|ECU School of Medicine, Leo Jenkins Cancer Center||Greenville, North Carolina 27858|
|Pottstown Memorial Regional Cancer Centre||Pottstown, Pennsylvania 19464|
|Santee Hematology Oncology||Sumter, South Carolina 29150|
|University Oncology and Hematology Associates||Chattanooga, Tennessee 37404|
|Lone Star Oncology Consultants, PA||Austin, Texas 78759|
|Center for Oncology Research and Treatment||Dallas, Texas 75230|
|Northern Utah Associates||Ogden, Utah 84403|
|Arlington-Fairfax Hematology Oncology P.C.||Arlington, Virginia 22205|