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Boehringer Ingelheim Broadens Its Breast Cancer Clinical Trial Program for the Investigational Compound Afatinib
Date:9/6/2011

reatment option for HER2-positive patients with advanced breast cancer in a pivotal phase III clinical trial called LUX-Breast 1. Studies 1200.89 and LUX-Breast 1 include biomarker testing of tumor tissues.

Breast cancer is the second-leading cause of cancer death in women after lung cancer.  An estimated 39,520 American women are expected to die from breast cancer in 2011.(1)  It is thought that women overexpress the HER2 protein in approximately 30 percent of advanced breast cancer cases.(2)  

"There is a need for more treatment options for patients with aggressive HER2-positive breast cancer. These studies are important because they will help us to further explore the potential of afatinib in this difficult-to-treat group of patients," said Andree Amelsberg, M.D., Executive Director, Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. 

About the Afatinib Clinical Program

The LUX trial program is a comprehensive and robust program that comprises more than 10 trials conducted across the globe, investigating afatinib for potential approval for a variety of solid tumor types, including NSCLC, breast and head and neck cancer.  In breast cancer specifically, the following trials are underway:

Afatinib in HER2-Positive Metastatic Breast Cancer After One Prior Trastuzumab Treatment (LUX-Breast 1)

LUX-Breast 1 is a global, open-label, randomized study in nearly 800 HER2-positive patients with advanced breast cancer after prior treatment with trastuzumab. The primary endpoint of the study evaluates whether treatment with afatinib can extend the time until cancer progresses (i.e., progression-free survival or PFS) as compared to continuing treatment with trastuzumab, when both are added to the standard chemotherapy treatment vinorelbine. Overall survival and safety are among the secondary endpoints that will be assessed in the trial.  For more information, please visit <
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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