Boehringer Ingelheim today announced the initiation of two phase II studies, 1200.89 and LUX-Breast 2, evaluating afatinib in patients with metastatic breast cancer, who have an overexpression of the erbB2 (HER2) protein, so called HER2-positive patients. 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 erbB2 (HER2)-overexpressing inflammatory breast cancer, one of the most aggressive forms of 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 erbB2 (HER2)-positive, metastatic breast cancer. The patients have progressed on currently available erbB2 (HER2) targeted treatments.
Afatinib is also currently being investigated in a pivotal phase III clinical trial, called LUX-Breast 1. LUX-Breast 1 is a global trial in patients with metastatic erbB2 (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 erbB2 (HER2) receptor. This overexpression of the erbB2 (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 erbB2 (HER2) negative tumours.
"There is an urgent need for more treatment options for patients with aggressive erbB2 (HER2)-positive breast cancer. 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", said Professor Nadia Harbeck, Director of the Interdisciplinary Breast Centre, University Hospitals Cologne, Germany.
The initiation of these new studies represents yet another important milestone for Boehringer Ingelheim to broaden and further develop its oncology pipeline across a range of different cancers.