IND 213 is an open-label, randomized, non-blinded Phase II study to assess the therapeutic combination of intravenously-administered REOLYSIN® given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer. Patients will receive paclitaxel weekly, on days 1, 8 and 15 of each twenty-eight day cycle, with either REOLYSIN® (test arm) or placebo (control arm) administered on days 1, 2, 8, 9, 15 and 16. Approximately fifty response-evaluable patients will be enrolled in each arm, after a six- to nine-patient safety run-in. The primary objective is progression-free survival. Secondary objectives include objective response rate, overall survival, circulating tumour cell counts, and the tolerability and toxicity of the treatment combination. Other objectives include the measurement of molecular factors which may be prognostic or predictive of response.
The study is being sponsored and conducted by the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) at Queen’s University in Kingston, Ontario.