This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.

PHASE3UnknownINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

January 18, 2022

Primary Completion Date

February 18, 2024

Study Completion Date

May 18, 2024

Conditions
Advanced Breast CancerFemale Breast Cancer
Interventions
DRUG

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。

DRUG

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。

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

Sponsors
All Listed Sponsors
lead

Ahon Pharmaceutical Co., Ltd.

OTHER