A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer
Inclusion Criteria:
- Patient with histologically proven breast cancer
- Surgical resection performed with clear margins (R0 resection)
- At least 1 histologically proven involved axillary node
- ER + or ER-
- Interval between surgery (2nd surgical procedure in case of multiple procedures) and
randomization inferior to 60 days
- Aged over 18 years, and more than 10-year life expectancy
- ECOG performance status 0-1
- Signed informed consent form prior to randomization
Exclusion Criteria:
- Bilateral breast cancer
- Inflammatory breast cancer
- Personal history of breast cancer
- Immunohistochemical only node involvement
- Intraductal breast cancer
- Distant metastases
- Contraindication to any drug contained in the chemotherapy regimens
- Any serious active disease or co-morbid medical condition including recent history of
severe sepsis and digestive inflammatory disease
- Poor renal function (creatinin level > 120 micromol/L), poor hepatic function (total
bilirubin level > 1 UNL), transaminases > 2.5 UNL)
- Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L;
Hemoglobin < 10 G/dL
- Poor contractile cardiac function (LVEF < 50%)
- Coronary disease
- Any history of cancer during the last 5 years, with the exception of basal cell
carcinomas or stage 0 (in situ) cervical carcinoma
- Pregnancy or breast feeding
- Absence of contraception in non menopausal women
- Adult patient unable to give informed consent because of intellectual impairment
- Concomitant participation to another trial