Clinical Trial Notes Factors Affecting Enrollment in a Randomized Controlled Trial for Japanese Metastatic Breast Cancer Patients (SELECT BC-FEEL)—A Prospective Study

To accelerate the completion of clinical trials, it is critical to obtain, at high rates, informed consent to participate from patients who are eligible. It is therefore important to know what factors affect the participation rates of eligible patients. Selection of effective chemotherapy for breast cancer and its successor selection of effective chemotherapy for breast cancer-CONFIRM are rando-mized controlled trials conducted for Japanese patients with chemotherapy-naı̈ve metastatic breast cancer. These trials are intended to compare the current standard chemotherapeutic regi-mens in the first-line setting, which are taxanes for selection of effective chemotherapy for breast cancer and anthracyclines for selection of effective chemotherapy for breast cancer-CONFIRM, respectively, and an oral regimen of TS-1 in terms of overall survival. We are conducting prospective studies to identify the factors affecting the rates at which informed consent is obtained in selection of effective chemotherapy for breast cancer and breast cancer-CONFIRM. We are using a self-administered questionnaire that we have developed to collect information regarding patients ’ characteristics and attitude to clinical trials. Key words: metastatic breast cancer – prospective cohort study – enrollment – informed consen