GSK's Tykerb enters Ph III breast cancer trial

UK-based drug major GlaxoSmithKline has announced its cancer treatments Tykerb (lapatinib) and trastuzumab will undergo Phase III clinical trials as a neoadjuvant for the treatment of breast cancer in collaboration with the Breast International Group.

The trial, entitled Neo-ALTTO, will be a three-arm, randomized, multicenter, open-label study of neoadjuvant lapatanib, neoadjuvant trastuzumab and a combination of both, in the treatment of 450 women with ErbB2-positive primary breast cancer. It will cover 130 trial centers in 26 countries and is hoped that it will discover molecular biomarkers that will help identify the benefits of the two drugs, as well as testing their safety and tolerability in this indication.

The trial will provide patients with six weeks of treatment as a monotherapy, followed by 12 weeks in combination with paclitaxel. Then the patients will undergo surgery followed by three courses of chemotherapy, then a further 34-week treatment period.