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Boehringer Ingelheim Broadens Its Breast Cancer Clinical Trial Program for the Investigational Compound Afatinib
Date:9/6/2011

RIDGEFIELD, Conn., Sept. 6, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. recently announced the initiation of two global phase II studies evaluating afatinib (BIBW 2992) in patients with inflammatory and metastatic breast cancer who have an overexpression of the erbB2 (human epidermal receptor 2 or HER2) protein, also known as HER2-positive patients. Afatinib is an investigational orally-administered irreversible inhibitor of the erbB family of receptor tyrosine kinases, specifically epidermal growth factor receptor (EGFR) and HER2.  Afatinib is in late-stage development in advanced breast cancer and non-small cell lung cancer (NSCLC).  The initiation of these studies represents another important milestone as Boehringer Ingelheim broadens and further develops its oncology pipeline across a range of different cancers.

Study 1200.89, "Afatinib (BIBW 2992) in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer," recently opened for recruitment in Australia, India and the United Kingdom, and will begin enrolling U.S. patients in January 2012.  This trial will investigate the efficacy and safety of afatinib for the treatment of patients with HER2-positive inflammatory breast cancer, one of the most aggressive forms of breast cancer.  Upon progression, patients may be further evaluated with a combination of afatinib and vinorelbine.

A second global trial being conducted outside of the U.S., 1200.98 (LUX-Breast 2), "Afatinib in HER2-Treatment Failures," began enrolling patients in Asia and the United Kingdom in May 2011 and is investigating the efficacy and safety of afatinib in patients with HER2-positive, metastatic breast cancer who have progressed on currently available HER2-targeted treatments.  This trial will evaluate afatinib initially alone and subsequently after progression in combination with either vinorelbine or paclitaxel.  

Afatinib is also being investigated as a potential t
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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