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

a href="http://clinicaltrials.gov/ct2/show/NCT01125566?term=LUX-Breast+1&rank=1">http://clinicaltrials.gov/ct2/show/NCT01125566?term=LUX-Breast+1&rank=1.

Afatinib in HER2-Treatment Failures (1200.98)

This global, non-randomized, open-label study began in May 2011 and will investigate the efficacy and safety of afatinib alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting. The study will recruit approximately 120 patients.  The primary endpoint of the study is objective response rate; secondary endpoints include best overall response (OR) during each treatment period, duration of OR, PFS and safety.  For more information, please visit http://clinicaltrials.gov/ct2/show/NCT01271725?term=afatinib+1200.98&rank=1.  

Afatinib in erbB2 (HER2)-Overexpressing Inflammatory Breast Cancer (1200.89)

This non-randomized, open-label study will investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include approximately 40 patients (combined in the United States and globally) who have or have not failed prior trastuzumab treatment. The primary endpoint of the study is clinical benefit rate assessed by complete response, partial response and stable disease for at least six months; secondary endpoints include OR, duration of OR, PFS and safety.  For more information, please visit

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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