Ingelheim, Germany, 29 August, 2011 – 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). 1
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. 2 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. 3