In the HER2CLIMB trial, the addition of tucatinib to Herceptin and Xeloda significantly improved the duration of the disease was stopped in patients with locally advanced, unresectable, or metastatic HER2-positive breast cancer.
HER2-positive patients enrolled in the trial were previously treated with Herceptin, Perjeta and Kadcyla, and 47% of patients enrolled had brain metastases. Patients were randomized to tucatinib plus Herceptin, tucatinib plus Xeloda or tucatinib plus Herceptin and Xeloda.
Tucatinib was administered orally twice daily in 300 mg doses.
At the interim analysis, 2 secondary endpoints, survival and PFS in the subgroup of patients with brain metastases, were also met. Overall survival was superior with the addition of tucatinib to Herceptin and Xeloda, showing a 34% reduction in the risk of death and reduced the risk of disease progressionby 52%.
The study found the triple combination to be manageable. Adverse events (AEs) seen with the addition of tucatinib included diarrhea, fatigue, vomiting and Hand-Foot Syndrom.
Reported severe AEs seen with the addition of tucatinib included increased aspartate aminotransferase, increased alanine aminotransferase, increased bilirubin and diarrhea.
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