Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.
- To evaluate the benefit from sequential administration of 3 courses of combination
chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the
5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.
- To compare the 5-year distant metastasis-free survival.
- To compare the 5-year event-free survival.
- To compare the 5-year overall survival.
- To compare the safety profiles for the two chemotherapy regimens.
- To identify and/or validate predictive-gene expression profiles of clinical
response/resistance to the two treatment regimens.
- To bank frozen and fixed tumor and frozen serum prospectively for future translational
studies in both genomics and proteomics (transcriptome and proteome analyses, tissue
- To compare the cost-effectiveness of these 2 regimens.
- To compare the quality-of-life of patients treated with these 2 regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status
(triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor [ER]
positive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and
cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks
in courses 4-6.
- Arm II: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone
every 3 weeks in courses 4-6.
In both arms, courses repeat every 21 days in the absence of disease progression or
Patients also complete a quality of life questionnaire periodically.
After completion of study treatment, patients are followed periodically for up to 10 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival (DFS) defined as a local, regional, or metastatic relapse, a contralateral breast cancer, or a death of any cause
at 5 years
Mario Campone, MD
ICO Centre Regional Rene Gauducheau
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
PACS08 - UC-0140/0610
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Colorado Cancer Research Program||Denver, Colorado 80224-2522|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|Duluth Clinic Cancer Center - Duluth||Duluth, Minnesota 55805-1983|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Green Bay Oncology, Limited at St. Mary's Hospital||Green Bay, Wisconsin 54303|
|Cancer Center of Kansas, PA - Wichita||Wichita, Kansas 67214|
|Roger Maris Cancer Center at MeritCare Hospital||Fargo, North Dakota 58122|
|Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center||Lincoln, Nebraska 68510|
|Oncology Associates at Rapid City Regional Hospital||Rapid City, South Dakota 57701|