Phase II study of weekly docetaxel and capecitabine in patients with metastatic breast cancer

Purpose: This phase 11 study evaluated the safety and efficacy of weekly docetaxel and capecitabine in patients with metastatic breast cancer. Patients and Methods: Thirty-nine patients with metastatic breast cancer received 30 mg/m(2) of docetaxel on days 1, 8, and 15 in combination with capecitabine 800 mg/m(2) twice daily on days 1 2 1, repeated every 28 days. Results: The 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). Conclusion: Weekly docetaxel with capecitabine was active with acceptable toxicities. Additional trials to define the optimal schedule of docetaxel and capecitabine are justified.