trastuzumab plus endocrine therapy (n=196) vs. trastuzumab plus chemotherapy (n=196)
randomized controlled trial
trastuzumab plus endocrine therapy
trastuzumab: on day 1 of study treatment as an initial loading dose of 8 mg/kg. Subsequent dosing and scheduling of trastuzumab was 6 mg/kg every 3 weeks / endocrine therapy
trastuzumab plus chemotherapy
trastuzumab: on day 1 of study treatment as an initial loading dose of 8 mg/kg. Subsequent dosing and scheduling of trastuzumab was 6 mg/kg every 3 weeks / chemotherapy
la/mBC - HR-positive - 1st line (L1)
open label
in 9 hospitals in China
P3 / nononferiority, PFS at 0.025 and HR <1.35 / All efficacy analysis will be performed based on the ITT population