Approximately 110 patients will be randomly assigned to receive either letrozole plus AS1402 or standard treatment with letrozole alone. The safety of the AS1402-letrozole combination will be evaluated and its efficacy compared with that of letrozole alone. Measures of efficacy will include response rates, time to tumor progression, progression-free survival and clinical benefit rate. Final results are expected in 2010.
The Phase II trial builds on a Phase I study in patients with heavily pre-treated breast cancer, which showed that AS1402 monotherapy was well-tolerated and was associated with prolonged stable disease in a number of patients. Hospitals in the US, Russia, Ukraine, Poland and France are taking part in the Phase II study.
Ursula Ney, Antisoma’s COO, said: “Worldwide, over 90,000 women each year receive endocrine treatment for advanced breast cancer, so many patients could benefit from any add-on therapy that improved outcomes in this setting. Our Phase II study rigorously tests the value of adding AS1402 to endocrine treatment and, if positive, will provide a firm basis for progress to a pivotal Phase III trial in breast cancer.”