Among the 13 patients with available PK data, we observed a trend towards higher exposure after the first dose in five patients who required subsequent dose reductions compared to those without dose reduction, although the apparent difference did not reach statistical significance (mean ± SD AUC 0‐t : 9,669 h·ng/mL ± 3,695 h·ng/mL vs. 6,047 h·ng/mL ± 3,206 h·ng/mL, respectively).
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An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial.
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