Boehringer Ingelheim Broadens its Breast Cancer Trial Programme for Afatinib*
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