Trial schedule and CONSORT diagram. A, Basic trial schedule. Prescreened patients positive for either p-ERK and/or CDK6 were eligible after experiencing RECIST v1.1 disease progression to their first or second treatment line for advanced disease. Treatment consisted of continuous binimetinib (45 mg orally twice a day) and palbociclib (100 mg/day, orally) from days 1 to 21 of 28-day cycles. Palbociclib was allowed to be escalated to 125 mg/day in case of patients showing acceptable tolerance to 100/day during cycle 1. Treatment continued until disease progression, unacceptable toxicity, or investigator decision. D, day. B, CONSORT diagram. * The most frequent reasons for not meeting inclusion criteria were having received less than one or more than two treatment lines for advanced TNBC (n = 9), not having experienced disease progression to the previous treatment line according to RECIST v1.1 (n = 9), and inadequate organ function (n = 2). Eval., evaluation.
Manso et al. (Mon,) studied this question.