Randomised phase II trial comparing vinorelbine and capecitabine with docetaxel and capecitabine chemotherapy for metastatic breast cancer

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2003
INTERVENTION: Randomisation will be stratified by previous anthracycline exposure. 1. Vinorelbine 25mg/m^2 intravenous (IV) 30 min DI + 8q 21 days. Capecitabine 1 g/m^2 orally, twice daily for 14 in every 21 days. 2. Docetaxel 75 mg/m^2 IV 60 min every 21 days with dexamethasone 8 mg twice daily for three days starting 24 hours before each docetaxel treatment. Capecitabine 1 g/m^2 orally, twice daily for 14 in every 21 days. Added 17 July 2008: the trial closed in 2006 due to poor recruitment. CONDITION: Breast cancer ; Cancer ; Breast PRIMARY OUTCOME: Toxicity, response and survival. SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: Metastatic breast cancer following initially histologically proven adenocarcinoma of the breast.
Epistemonikos ID: d01226da99c46148706d2071f1ce29430be8d2c0
First added on: Aug 21, 2024