GlaxoSmithKline results mean early halt to trial

Encouraging results from a phase III trial into a treatment for breast cancer have enabled GlaxoSmithKline (GSK) to end the trial early and extend the offering of the drug being tested.

The trial evaluated the efficacy of the drug Tykerb as a treatment along with capecitabine for women with certain types of breast cancer.

And, due to positive interim analysis results, GSK has called a halt to the trial based on the recommendation of an Independent Data Monitoring Committee (IDMC).

“We are extremely encouraged by the data which suggests that Tykerb may offer significant benefit as an oral medication in combination with chemotherapy for patients with advanced or metastatic ErbB2 positive breast cancer, and whose disease has progressed on previous treatment regimens, including Herceptin,” said Dr Paolo Paoletti, senior vice president of the Oncology Medicine Development Centre, at GSK.

“On the basis of this and other data we now plan to file in the US and Europe during the second half of 2006.”

GSK has said it will continue to follow women involved in the trial and will offer those treated with just capecitabine the option to also have Tykerb administered.

The trial involved 392 patients, with 321 ? split 161 and 160 between the monotherapy and combination therapy ? used for the analysis.

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