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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
array analyses).
- 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
unacceptable toxicity.
Patients also complete a quality of life questionnaire periodically.
After completion of study treatment, patients are followed periodically for up to 10 years.
Interventional
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
No
Mario Campone, MD
Principal Investigator
ICO Centre Regional Rene Gauducheau
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
PACS08 - UC-0140/0610
NCT00630032
September 2007
Name | Location |
---|---|
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 |