This will be the first phase III study to investigate whether adjuvant treatment with Tykerb will improve disease-free survival in women with early-stage HER2 breast cancer, including those with positive and negative node involvement.
Between 20% and 30% of human breast cancers overexpress HER2. Because of the distinct clinical features of HER2-positive breast cancer, women have a high risk of disease recurrence so poorer prognosis.
“Researchers are continually seeking ways to stay one step ahead of cancer. We must be proactive with treatments for women who have a distinctive disease prognosis – those with HER2-positive breast cancer,” said Paolo Paoletti, senior vice president of the Oncology Medicine Development Center at GSK.
The study is designed to compare the efficacy and safety of lapatinib versus placebo in women treated for early-stage, HER2-positive breast cancer who have no clinical or radiographic evidence of disease. The primary efficacy endpoint for analysis is disease-free survival.
Tykerb is seen as a rival to current breast cancer drug Herceptin and is currently being reviewed for use in women with advanced breast cancer who have failed to respond to Herceptin.