Efficacy and safety endpoints and statistical considerations
TNBC, PD, death, deaths
ADVERSE EVENTS, DISEASE PROGRESSION
The total accrual duration was expected to be 30 months. The minimum follow-up time after the inclusion of the last patient for the primary analysis is 12 months. The primary analysis was time-driven and planned to take place after at least 42 months from start of the trial. The primary endpoint for this trial was progression-free survival at 12 months (PFS12m). PFS was calculated from the date of registration until progression according to RECIST v1.1 or death of any cause, whichever occurred first. Secondary endpoints include: objective response rate (ORR)—defined as proportion of patients achieving CR or PR (RECIST v1.1) during trial treatment; duration of response (DOR)—defined as time from CR or PR (RECIST v1.1) achievement with investigational therapy, until documented progression, relapse, or death due to disease progression; time to progression (TTP)—defined as time from registration until progression (RECIST v1.1) or death due to PD (equivalent to PFS as all deaths were considered as cancer-related); PFS; overall survival (OS)—defined as time from registration until death from any cause; adverse events (AE).For an alpha = 0.1 with 80% power 47 patients were needed to test the null hypothesis of ≤ 25% of patients to be progression-free at 12 months against the alternative hypothesis of ≥ 40% of patients being progression free at 12 months [with the reference of 25% for the null hypothesis taken from the TNBC subgroup of the ATHENA trial n = 585 TNBC patients