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Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-AACR San Antonio Breast Cancer Symposium
Date:12/9/2011

nths, which translates to an overall response rate of 64% and a clinical benefit rate of 72%.  In addition, for the 7 patients in the trial who had previously been treated with lapatinib, 1 (14%) patient experienced a complete response, 3 (43%) patients experienced a partial response and 1 (14%) patient experienced stable disease for greater than 6 months, which translates to an overall response rate of 57% and a clinical benefit rate of 71%.  The median progression free survival (PFS) for patients who had not received prior treatment with lapatinib was 40.3 and the median PFS for the patients who had received prior lapatinib treatment was 35.9 weeks. 

A Phase II, Randomized, Open-label Study of Neratinib Versus Lapatinib Plus Capecitabine for 2nd/3rd-line Treatment of HER2+ Locally Advanced or Metastatic Breast Cancer

The Phase II randomized trial of PB272 given as monotherapy versus the combination of lapatinib given in combination with capecitabine was conducted at numerous locations in the United States, Europe and Asia.  The trial was sponsored by Pfizer. In the trial, patients who had confirmed HER2+ metastatic or locally advanced breast cancer and disease progression following prior treatment with trastuzumab and taxane chemotherapy were enrolled.  Patients were randomized to receive either PB272 given as monotherapy daily at a dose of 240 mg per day or the combination of lapatinib given daily at a dose of 1,250 mg per day in combination with capecitabine given at a dose of 2,000 mg/m2 (1,000 mg/m2 twice daily) on Days 1 to 14 of each 21-day cycle.

The results of the study showed that the most frequently observed severe adverse events in the trial were diarrhea and palmar-plantar erythrodysesthesia (PPE, or hand-foot syndrome).  More specifically, 28% of the patients in the neratinib arm of the trial and 10% of the patients in the lapatinib/capecitabine combination arm of the trial experience
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