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news.Boehringer Ingelheim has started the Phase III clinical trial - 'LUX-Breast 1 Trial' to evaluate Afatinib for the treatment of patients with advanced (metastatic) breast cancer.
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Afatinib is an oral compound targeted therapy that irreversibly inhibits both the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread.
Boehringer Ingelheim claimed that LUX-Breast 1 Trial is the first pivotal study to evaluate Afatinib in breast cancer and this investigation is expected to widen the scope of potential cancer types for which Boehringer Ingelheim’s oncology portfolio may be suitable.
LUX-Breast I is an open-label randomised Phase III pivotal study in patients with advanced breast cancer after prior treatment with trastuzumab who have an over-expression of the HER2 protein (HER2-positive patients).
Afatinib Phase III trial is conducted to study whether treatment with the drug can extend the lives of these patients before their cancer progresses (i.e. progression-free survival, PFS) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine.
Additionally, overall survival, tolerability and safety are also expected to be assessed in the study.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said that they have seen positive results in their proof-of-concept studies for Afatinib in breast cancer and were glad to advance the programme into pivotal phase III.
“We are delighted to be able to initiate this important trial together with investigators to assess the value of Afatinib for women with advanced breast cancer,” Dugi said.