Lapatinib In The Treatment Of Breast Cancer

Based on the unanimous recommendation of an Independent Data Monitoring Committee (IDMC), GlaxoSmithKline announced that it has halted enrollment in its Phase III clinical trial evaluating the combination of Tykerb (lapatinib ditosylate) and capecitabine (Xeloda(R)) versus capecitabine alone.

The trial evaluated women with refractory advanced or metastatic breast cancer who have documented ErbB2 (HER2) overexpression and whose disease progressed following treatment with trastuzumab (Herceptin(R)) as well as other cancer therapies. A pre-planned interim analysis of 321 patients in the study yielded statistically significant results, exceeding the primary endpoint.

According to the study protocol, the pre-planned interim analysis was reviewed by the IDMC, which is comprised of medical oncology experts and a statistician. The IDMC unanimously recommended halting enrollment in the study because it exceeded its primary endpoint of time to disease progression, or TTP, for women receiving the combination of Tykerb and capecitabine. The IDMC made their recommendation based on pre-specified stopping rules outlined in their charter. All women currently enrolled in the trial will continue to be followed and those who are receiving capecitabine alone will be offered the option of switching to the combination therapy of capecitabine and Tykerb in consultation with their physician.






Posted by: Janet    Source