Puma begins Phase II trial of breast cancer drug neratinib

The open label single arm Phase II trial of PB272 monotherapy will involve a total of 70 patients with HER2-positive early stage breast cancer who have previously received adjuvant treatment with trastuzumab.

During the trial, patients will be given extended adjuvant treatment with neratinib for a period of one year.

Initially, patients will receive primary prophylaxis with high dose loperamide 16mg per day in order to attempt to reduce the neratinib-related diarrhea.

The trial’s primary endpoint is reduction in the incidence and severity of diarrhea.

Puma Biotechnology chief executive officer and president Alan Auerbach said: "Because the ExteNET Phase III trial was run prior to the implementation of loperamide prophylaxis in clinical trials of neratinib, in the ExteNET Phase III trial neratinib was administered without loperamide prophylaxis.

"The results from this Phase II study will give us a better understanding of the safety of neratinib in the extended adjuvant setting with concurrent high dose loperamide administered and, importantly, to what degree the grade 3 neratinib-related diarrhea can be reduced."

The company intends to report initial results from the trial by the end of 2015 and this data will be included in its NDA filing for neratinib in the extended adjuvant setting, which is currently expected for the first quarter of 2016.