312
Participants
Start Date
January 18, 2022
Primary Completion Date
February 18, 2024
Study Completion Date
May 18, 2024
FCN-437c,Fulvestrant,Goserelin acetate
FCN-437c:available in 25mg and 100mg capsules for oral administration on an empty stomach. 200mg once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment until progressive disease。 Fulvestrant:500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles ; Goserelin acetate:premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。
Placebo,Fulvestrant,Goserelin acetate
Placebo:available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。 Fulvestrant:500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles; Goserelin acetate:premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。
RECRUITING
Fudan University Shanghai Cancer Center, Shanghai
Lead Sponsor
Ahon Pharmaceutical Co., Ltd.
OTHER