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Boehringer Ingelheim Initiates Phase III Clinical Trial With Afatinib in Advanced Breast Cancer
Date:12/8/2010

RIDGEFIELD, Conn. Dec. 8, 2010 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced the initiation of a phase III clinical trial in the United States to investigate one of its oncology pipeline compounds, afatinib* (BIBW 2992), for the treatment of patients with advanced (metastatic) breast cancer.  Afatinib is an investigational orally administered irreversible inhibitor of both the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinases.  Afatinib is under development in several solid tumors including non-small cell lung cancer (NSCLC) and head and neck cancer.

The LUX-Breast 1 phase III trial is the first pivotal study to evaluate afatinib in breast cancer and represents an important milestone for Boehringer Ingelheim to broaden its oncology development activities beyond NSCLC and head and neck cancer.  LUX-Breast 1 is a global, open-label, randomized study in patients with advanced breast cancer after prior treatment with trastuzumab who have an over-expression of the HER2 protein (HER2-positive patients). The primary endpoint of the study evaluates whether treatment with afatinib can extend the lives of these patients before their cancer progresses (i.e., progression-free survival or PFS) as compared to continuing treatment with trastuzumab, when both are added to the standard chemotherapy treatment vinorelbine. Overall survival and safety are among the secondary endpoints that will be assessed in the trial.

"Based on results from our proof of concept studies for afatinib in breast cancer, we are pleased to advance this program into a pivotal phase III trial," said Christopher Corsico, M.D., M.P.H., U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc.  "We are initiating this important trial together with a team of investigators around the world to assess the clinical utility of afatinib for women with metastatic breast cancer."

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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