X Versus Placebo as Postoperative Adjuvant Treatment for Elder Breast Cancer

Exclusion Criteria

• •·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.
• •Prior systemic therapy for breast cancer.Or prior therapy with capecitabine for any malignancy.
• •Prior radiotherapy for breast cancer.
• •Bilateral invasive breast cancer.
• •Any T4 or N2-3 or M1 tumour.
• •Pre-existing grade \>= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 \[NCI CTC v-2.0\]).
• •Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled HA 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.
• •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.