The trial will be conducted through the NCCTG, a network of cancer specialists at community clinics, hospitals, and medical centers in the US and Canada. The research base for NCCTG is located at Mayo clinic in Rochester, Minnesota.
According to the company, the proposed trial design is to test two different dosing schedules of pixantrone. Patients on the trial will be randomized to receive either 180 mg/m2 every three weeks, or 85 mg/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 the company, 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.
“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.”
Will the new trial design benefit breast cancer patients?
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