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news.Boehringer Ingelheim Pharmaceuticals has commenced two Phase II trials to investigate afatinib (BIBW 2992) in patients suffering from inflammatory and metastatic breast cancer.
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Afatinib is an experimental orally-administered irreversible inhibitor of the erbB family of receptor tyrosine kinases, specifically epidermal growth factor receptor (EGFR) and HER2.
The trials, 1200.89, ‘Afatinib (BIBW 2992) in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer’ and 1200.98 (LUX-Breast 2), ‘Afatinib in HER2-Treatment Failures,’ aim to investigate the efficacy and safety of afatinib for the treatment of patients with HER2-positive inflammatory breast cancer.
Recruitment for the study 1200.89 recently opened in Australia, India and the United Kingdom, and enrollments will begin in US in January 2012.
The trial will investigate the efficacy and safety of afatinib for the treatment of patients with HER2-positive inflammatory breast cancer and upon progression, patients will undergo evaluation with a combination of afatinib and vinorelbine.
The second global trial conducted outside of the US, 1200.98 (LUX-Breast 2) began enrolling patients in Asia and the UK 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.
The trial will evaluate afatinib initially alone and subsequently after progression the combination of vinorelbine or paclitaxel.
Afatinib is also being investigated as a potential treatment option for HER2-positive patients with advanced breast cancer in a pivotal phase III clinical trial called LUX-Breast 1.