Breast Cancer Clinical Trial
Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
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.
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.
Docetaxel Arm: 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.
Ixabepilone Arm: 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.
Histologically proven invasive unilateral breast cancer (regardless of the type)
Initial clinical condition compatible with complete initial resection
No residual macro or microscopic tumor after surgical excision
Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :
Stage II or III disease
pT >20 mm (T1-4)
Patients must meet 1 of the following hormone-receptor criteria:
Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)
Node-negative patients: triple-negative* tumor only
NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative
Must be able to begin chemotherapy no later than day 49 after the initial surgery
Clinically or radiologically detectable metastases (M0)
Bilateral breast cancer or contralateral ductal carcinoma in situ
Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type
Any tumor ≥T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)
HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive
Any clinically or radiologically suspect and non-explored damage to the contralateral breast
Pre- or postmenopausal
ECOG performance status 0-1
Peripheral neuropathy ≤grade 1
Neutrophil count ≥2,000/mm³
Platelet count ≥100,000/mm³
Hemoglobin >9 g/dL
AST and ALT ≤1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤2.5 times ULN
Total bilirubin ≤1.0 times ULN
Serum creatinine ≤1.5 times ULN
LVEF ≥50% by MUGA scan or echocardiography
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer
Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study
Clinically significant cardiovascular disease within the past 6 months including any of the following:
Congestive heart failure
Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)
Cerebral vascular accidents
Known prior severe hypersensitivity reactions to agents containing Cremophor EL
Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Patients deprived of liberty or placed under the authority of a tutor
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered
At least 3 weeks since prior major surgery and adequately recovered
No prior chemotherapy, hormonal therapy, or radiotherapy
More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:
No concurrent participation in another therapeutic trial involving an experimental drug
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There are 86 Locations for this study
Scottsdale Arizona, 85259, United States
Denver Colorado, 80224, United States
Jacksonville Florida, 32224, United States
South Bend Indiana, 46601, United States
Cedar Rapids Iowa, 52403, United States
Sioux City Iowa, 51101, United States
Wichita Kansas, 67214, United States
Duluth Minnesota, 55805, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Fargo North Dakota, 58122, United States
Dayton Ohio, 45429, United States
Danville Pennsylvania, 17822, United States
Rapid City South Dakota, 57701, United States
Green Bay Wisconsin, 54303, United States
Brussels , 1000, Belgium
Chimay , B-646, Belgium
Huy , 4500, Belgium
Kortrijk , B-850, Belgium
Mons , B-700, Belgium
Ottignies , B-134, Belgium
Yvoir , 5530, Belgium
Albi , 81000, France
Angers , 49036, France
Annecy , 74011, France
Auxerre , 89011, France
Avignon , 84082, France
Blois , 41000, France
Bordeaux , 33076, France
Bordeaux , F-330, France
Boulogne Sur Mer , 62200, France
Bourg-En-Bresse , 01012, France
Brest , 29609, France
Caen , 14076, France
Chambery , 73011, France
Chateaubriant cedex , 44110, France
Clermont-Ferrand , 63011, France
Cornebarrieu , 31700, France
Creteil , 94010, France
Dax , 40107, France
Dijon , 21079, France
Epinal , 88021, France
Ermont , 95120, France
Le Chesnay , 78157, France
Le Havre , 76600, France
Lormont , 33310, France
Lyon , 69373, France
Mareuil Les Meaux , 77100, France
Marseille , 13273, France
Metz , 57038, France
Metz , 57070, France
Mont-de-Marsan , 40000, France
Montauban , 82017, France
Montfermeil , 93370, France
Montlucon , 03113, France
Mulhouse , 68070, France
Muret , 31600, France
Neuilly sur Seine , 92200, France
Nice , 06189, France
Nimes , 30907, France
Paris , 75015, France
Paris , 75248, France
Pau , 64046, France
Perigueux , 24004, France
Perpignan , 66000, France
Reims , 51056, France
Reims , F-511, France
Rennes , 35042, France
Rodez , 12027, France
Saint Brieuc , F-220, France
Saint Cloud , 92211, France
Saint Jean , 31240, France
Saint Priest en Jarez , 42270, France
Saint-Herblain , 44805, France
Strasbourg , 67000, France
Strasbourg , 67065, France
Tarbes , 65000, France
Thionville , 57312, France
Toulouse , 31052, France
Toulouse , 31078, France
Tours , 37044, France
Vandoeuvre-les-Nancy , 54511, France
Vannes , 56001, France
Villejuif , F-948, France
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