Randomized double-blind phase 2 trial of 3 doses of TAS-108 in patients with advanced or metastatic postmenopausal breast cancer
Buzdar A et al. – TAS–108 at 40mg and 80mg daily demonstrated clinical activity with an encouraging duration of benefit. Because of its superior safety profile, TAS–108 40mg daily is recommended for further development.
In this randomized, double-blind, multicenter study, TAS-108 was administered daily at a dose of 40mg, 80mg, or 120mg to postmenopausal patients with locally advanced, or inoperable, or metastatic hormone-receptor positive breast cancer.
The primary efficacy outcome was clinical benefit (CB), defined as the total number of patients who achieved a complete response, a partial response, or stable disease for ≥24weeks.
The study was a 2-stage design in which 19 patients per dose group were planned in the first stage.
If at least 3 patients in any dose group achieved a CB, then that dose group was to be allowed to continue enrolling for the second stage, and the group could include up to a total of 60 patients.
The 40-mg and 80-mg groups met the criterion and enrolled patients into the second stage.
In the 40-mg group, there were 13 CB events in 60 patients (21.7%); and, in the 80-mg group, there were 12 CB events in 60 patients (20%).
The 120-mg daily dose was stopped early, because it failed to achieve the criterion.
For the 40-mg and 80-mg groups, the median time to progression was 15.0weeks and 15.9weeks, respectively.
Only 1 drug-related serious adverse event (grade 3 hyperglycemia) was reported.
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