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DAWNA-1, 2021 NCT03927456

dalpiciclib plus fulvestrant (n=241) vs. fulvestrant (n=120)

randomized controlled trial

Studied treatment

dalpiciclib plus fulvetrant
dalpiciclib: PO 150mg/day for 3-weeks on and 1-week off in each 4-cycle / fulvestrant: IM 500mg on day 1 and 15 of the first cycle and on day 1 of each subsequent 4-week cycle.

Control treatment

placebo (matching dulpaciclib) plus fulvestrant
fulvestrant: IM 500mg on day 1 and 15 of the first cycle and on day 1 of each subsequent 4-week cycle.

Patients

la/mBC - HR-positive - 2nd line (L2)

Method

double blind

39 centers in China

P3 / 1-sided at 0.025 for PFS with 1IA (α = 0.0074 ) and final analysis (α = 0.0227)

Remark

dalpiciclib added to fuvestrant improved significantly PFS compate to fulvestrant alone, in patients with HR-positive, and HER2-negaive BC.