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Boehringer Ingelheim announced yesterday the initiation of two Phase II studies, 1200.89 and LUX-Breast 2, evaluating afatinib in patients with HER2-positive, metastatic breast cancer.
Afatinib is an irreversible ErbB Family Blocker, which binds to all erbB-family kinases, including erbB2 (HER2).
The 1200.89 study is investigating the efficacy and safety of afatinib for the treatment of patients with HER2-overexpressing inflammatory breast cancer.
The LUX-Breast 2 study, which started enrolling patients in May this year, is investigating the efficacy and safety of afatinib in patients with HER2-positive, metastatic breast cancer.
The patients have progressed on currently available HER2 targeted treatments. Afatinib is also currently being investigated in a pivotal phase III clinical trial, called LUX-Breast 1, which is a global trial in patients with metastatic HER2-positive breast cancer after prior treatment with trastuzumab.
The trial investigates whether treatment with afatinib can extend the lives of these women before their cancer progresses (progression-free survival) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine.
Both, the LUX-Breast 1 and study 1200.89 include thorough biomarker testing of tumour tissues. Approximately 20-30% of women with breast cancer overexpress the HER2 receptor.
This overexpression of the HER2 protein is associated with a more aggressive form of breast cancer and a greater risk of disease progression and death compared to women with HER2 negative tumours.
“There is an urgent need for more treatment options for patients with aggressive HER2-positive breast cancer,” said Professor Nadia Harbeck, Director of Interdisciplinary Breast Centre at University Hospitals in Cologne, Germany.
“These studies are important because they will help us to further explore the potential of the novel compound afatinib to fill this gap in this difficult to treat group of patients.”
