Phase II Study of Weekly Docetaxel and Capecitabine in Patients with Metastatic Breast Cancer

PurposeThis phase II study evaluated the safety and efficacy of weekly docetaxel and capecitabine in patients with metastatic breast cancer.Patients and MethodsThirty-nine patients with metastatic breast cancer received 30 mg/m2 of docetaxel on days 1, 8, and 15 in combination with capecitabine 800 mg/m2 twice daily on days 1- 21, repeated every 28 days.ResultsThe median number of treatment cycles was 4 (range, 1-20 cycles). Grade 3 toxicities per patient were asthenia (n = 7; 18%), diarrhea (n = 7; 18%), nausea/vomiting (n = 5; 13%), stomatitis (n = 5; 13%), neutropenia (n = 5; 13%), and hand-foot syndrome (n = 4; 10%). There were only 2 grade 4 toxicities, febrile neutropenia and pulmonary embolism. The overall response rate was 44% (95% confidence interval (CI), 28%-60%), median duration of response was 9.1 months (95% CI, 6.2-12 months), and median time to progression was 5.5 months (95% CI, 3.7-7.3 months).ConclusionWeekly docetaxel with capecitabine was active with acceptable toxicities. Additional trials to define the optimal schedule of docetaxel and capecitabine are justified.