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news.Boehringer Ingelheim Pharmaceuticals has initiated LUX-Breast 1 Phase III clinical trial in the US to investigate one of its oncology pipeline compounds, Afatinib (BIBW 2992), for the treatment of patients with advanced (metastatic) breast cancer.
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Afatinib is an investigational orally administered irreversible inhibitor of both the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinases.
Boehringer Ingelheim said that LUX-Breast 1 is a global, open-label, randomised 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.
Boehringer Ingelheim US medical director said that based on results from the proof of concept studies for Afatinib in breast cancer, we are pleased to advance this program into a pivotal Phase III trial.
"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," Christopher Corsico.