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TYKERB(R) (Lapatinib) to be Investigated in Landmark Early Breast Cancer Trial
Date:5/12/2008

PHILADELPHIA, May 12 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK), in collaboration with the Breast International Group (BIG), a leading academic breast cancer research network, and one of its member groups, the Spanish Breast Cancer Cooperative Group (SOLTI), today announced the start of a global Phase III study that will examine the role of TYKERB(R) in the treatment of early breast cancer. Neo-ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) will evaluate and compare the rate at which cancer cells disappear in the breast following treatment with TYKERB and/or trastuzumab before surgery in women with early-stage HER2-positive breast cancer. This type of treatment is referred to as neo-adjuvant therapy. TYKERB is an investigational drug and has not yet been approved for this indication.

"The evolution seen in breast cancer care has been tremendous in the last few decades," said Dr. Jose Baselga, Co-Chair on Neo-ALTTO and Chair of the SOLTI Group, Spain. "Surgery, in the form of a radical mastectomy of the breast, was traditionally the first line treatment offered to patients with little or no improvement in overall survival. Now we have a range of sophisticated targeted treatments that can significantly delay disease progression and increase survival. Through trials such as Neo-ALTTO, oncologists may be better able to optimize the use of these agents."

One in four women diagnosed with early breast cancer have tumors that are HER2-positive.(1) It is well recognized that these women have a higher risk of their cancer returning - either at the location of the original tumor or when the cancer spreads to other organs - even after receiving additional therapies.(1)

"The launch of Neo-ALTTO is extremely exciting as this study will help physicians answer important clinical questions relating to the neoadjuvant treatment regimen of HER2-positive breast cancer," said Dr. Martine Piccart, Chairperson of the Breast
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SOURCE GlaxoSmithKline; Breast International Group; SpanishBreast Cancer
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