TYKERB(R) (Lapatinib) to be Investigated in Landmark Early Breast Ca... (International Group Institute JulesBorde...)

TYKERB(R) (Lapatinib) to be Investigated in Landmark Early Breast Cancer Trial

Date:5/12/2008

International Group, Institute Jules Bordet, Brussels, and investigator on Neo-ALTTO. "All too often clinicians and patients face the problem of disease recurrence, and women with high levels of HER2 protein are at a greater risk of this occurring. It is vital that early stage breast cancer is treated effectively from the outset with the right combination or sequence of therapies."

Neo-ALTTO is a three-arm, randomized, multi-center, open-label Phase III study of neoadjuvant TYKERB, neoadjuvant trastuzumab and a combination of neoadjuvant TYKERB and trastuzumab in women with HER2-positive primary breast cancer. After treatment for six weeks, the same targeted therapy will be repeated for 12 weeks with the addition of paclitaxel. Surgery will be performed on all patients, after which each patient will receive three courses of chemotherapy followed by the same targeted therapy for 34 weeks.

The primary objective of Neo-ALTTO is to evaluate and compare the rate of pathological complete response (or complete eradication of the tumor) at the time of surgery as well as understand the biological difference of the three treatment regimens using a neoadjuvant approach. Secondary objectives include measurements of safety and tolerability, tumor response rate, disease-free survival and overall survival. Target enrollment is 450 patients with 130 clinical trial centers participating across 26 different countries.

It is hoped that Neo-ALTTO will lead to the discovery of new molecular biomarkers that help to better identify the benefits of TYKERB or trastuzumab.

"GSK is proud to collaborate with such esteemed research groups as BIG and SOLTI for the study of TYKERB in this early breast cancer setting," said Paolo Paoletti, MD, Senior Vice President, Oncology Medicines Development Center of GSK. "This important global Phase III study, which has been enrolling within a year of the FDA approval of TYKERB, demonstrates the confidence that the oncolo
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