A phase I trial of 100mg/m² docetaxel in patients with advanced or recurrent breast cancer

Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m². Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m² were 22.1%, 23.3%, and 36.0%, respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m², and Japanese guidelines also recommend a dose of 100 mg/m². However, the approved dose in Japan is up to 75 mg/m². We have launched a phase I trial evaluating 100 mg/m² docetaxel in patients with advanced or relapsed breast cancer. The major eligibility criteria are as follows: age ≥20 years, pathologically diagnosed breast cancer, recurrent or advanced breast cancer, a good performance status, and HER2 [human epidermal growth factor receptor 2] negative. The primary endpoint is demonstrated safety of 100 mg/m² docetaxel. This study will clarify whether 100mg/m² docetaxel can be administrated safely in Japanese patients with advanced or recurrent breast cancer.