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Puma Biotechnology Announces Results from ExteNET Phase III Clinical Trial of Neratinib

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Clinical Data Puma Biotechnology announced the ExteNET Phase 3 trial of neratinib in patients with early stage HER2-positive breast cancer in the journal The Lancet Oncology.  The trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab.  "The study demonstrated that the trial hit its primary endpoint and that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009)".  Alan H. Auerbach, Chief Executive Officer and President of Puma said that the trial was "the first randomized trial to demonstrate a statistically significant DFS benefit using a HER2 targeted drug in the extended adjuvant treatment of patients with early stage HER2 positive breast cancer who have previously been treated with adjuvant trastuzumab".
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Catalyst Date
Occurred on:
Feb 11, 2016
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Related Keywords Extenet, Phase 3 Data, Neratinib, Her2-positive Breast Cancer