Cell Therapeutics has entered into an agreement with the North Central Cancer Treatment Group (NCCTG) to conduct a Phase II study of Pixantrone in patients with HER2-negative metastatic breast cancer who have tumour progression after at least two, but not more than three, prior chemotherapy regimens.
Cell Therapeutics said that the proposed trial design is to test two different dosing schedules of Pixantrone. Patients on the trial are expected to be randomised to receive either 180mg/m2 every three weeks, or 85mg/m2 weekly for three weeks with a one-week break.
The goal of the trial would be to test the safety and efficacy of each regimen and potentially select the one with the best benefit/risk profile for further development in a Phase III trial against a standard second- or third-line treatment.
Jack Singer, chief medical officer of Cell Therapeutics, said: "We are very pleased that the NCCTG has selected Pixantrone for this study. Patients with HER2-negative breast cancer who have relapsed after primary chemotherapy have a need for effective and well-tolerated new agents. Although highly active, usage of drugs in the anthracycline class as salvage agents has declined, predominantly due to concerns regarding cardiac toxicity.
"Based on its safety and activity in non-Hodgkin's lymphoma, Pixantrone has the potential to be an active agent in breast cancer that could be safely used in this setting. We look forward to the NCCTG initiating this trial".