Puma presents 'positive' PB272 Phase II data from I-SPY 2 trial Puma Biotechnology announced the presentation of "positive" results from the Phase II clinical trial of Puma's investigational drug PB272 for the neoadjuvant treatment of breast cancer, or I-SPY 2 trial, in an oral presentation. The presentation entitled “Neratinib plus Standard Neoadjuvant Therapy for High-Risk Breast Cancer: Efficacy Results from the I-SPY 2 TRIAL” was presented today at the session entitled “Clinical Trials Symposium: Biomarker Driven Clinical Trials.” The I-SPY 2 TRIAL is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or higher breast cancer that addresses whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy. The primary endpoint is pathological complete response in the breast and the lymph nodes at the time of surgery. The goal of the trial is to match investigational regimens with patient subsets on the basis of molecular characteristics that benefit from the regimen. The trial enrolled patients who had a high risk of relapse using up-front tumor profiling.