Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer (TavIx)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.
Drug: epirubicin hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Disease-free survival (DFS) defined as a local, regional, or metastatic relapse, a contralateral breast cancer, or a death of any cause [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
- DFS for triple-negative and ER+/PR-/HER2- subgroups [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
- Distant metastasis-free survival for whole population and subgroups [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
- Event-free survival defined as local, regional, or metastatic relapse, a contralateral breast cancer, a second cancer, or death of any cause [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: at 5 years ] [ Designated as safety issue: No ]
- Toxicity as measured by CTC-AE scale version [ Time Frame: During treatment phase ] [ Designated as safety issue: Yes ]
- Biotheque transcriptome and proteome analysis [ Time Frame: after survival analysis ] [ Designated as safety issue: No ]
- Quality of life as measured by QlQ C30/Br23 [ Time Frame: During treatment phase ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
500 mg/m2 every 3 weeksDrug: Docetaxel
100 mg/m2 every 3 weeksDrug: epirubicin hydrochloride
100 mg/m2 every 3 weeksDrug: fluorouracil
500 mg/m2 every 3 weeks
Experimental: Arm B
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
500 mg/m2 every 3 weeksDrug: epirubicin hydrochloride
100 mg/m2 every 3 weeksDrug: fluorouracil
500 mg/m2 every 3 weeksDrug: ixabepilone
40 mg/m2 every 3 weeks
- 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 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.
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|Principal Investigator:||Mario Campone, MD||ICO Centre Regional Rene Gauducheau|