EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer

Exclusion Criteria

• •* Renal function: creatinine \<= 175 mmol/l (2 mg/dl); creatinine clearance \>= 60 ml/min;
• •* Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.
• •Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.
• •Patients able to comply with treatment and study follow-up.
• •Negative pregnancy test done in the 14 prior days to randomization.
• •Prior systemic therapy for breast cancer.
• •Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
• •Prior radiotherapy for breast cancer.
• •Bilateral invasive breast cancer.
• •Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
• •Any T4 or M1 tumour.
• •Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.
• •HER2 positive breast cancer (IHC 3+ or positive FISH result).
• •Pre-existing grade \>= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 \[NCICTC v-2.0\]).
• •Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled hypertension or high risk arrhythmias.
• •History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.
• •Active uncontrolled infection.
• •Active peptic ulcer; unstable diabetes mellitus.
• •Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
• •Chronic treatment with corticosteroids.
• •Contraindications for corticosteroid administration.
• •Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.
• •Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
• •Concomitant treatment with another therapy for cancer.
• •Males.