A randomised phase II study comparing capecitabine with capecitabine and oral cyclophosphamide in patients with advanced breast cancer

INTERVENTION: Capecitabine days 1‐28 of 28 day cycle vs capecitabine days 1‐28 plus oral cyclophosphamide days 1‐14 of 28 day cycle. CONDITION: Advanced breast cancer PRIMARY OUTCOME: Best tumour response Toxicity assessed thoughout treatment SECONDARY OUTCOME: Survival measures Symptom response INCLUSION CRITERIA: Histological or cytological evidence of breast carcinoma with at least one of the following: distant metasteses, T4 or N2 or N3, or loacal recurrence following mastectomy;measurable disease; treatment with palliative intent; performace status 0‐3 (WHO); aequate bone marrow, renal and liver fnction and creatinine clearance > 50ml/min.