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

PHASE3UnknownINTERVENTIONAL
Enrollment

434

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

September 20, 2024

Study Completion Date

March 2, 2025

Conditions
Advanced Breast CancerFemale Breast Cancer
Interventions
DRUG

FCN-437c, Letrozole or anastrozole, 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。Letrozole or anastrozole:Letrozole 2.5 mg or anastrozole 1 mg once daily;Goserelin acetate:premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。

DRUG

Placebo, Letrozole or anastrozole, Goserelin acetate

"Placebo:available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。~Letrozole or anastrozole:Letrozole 2.5 mg or anastrozole 1 mg once daily;~Goserelin acetate:premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。"

Trial Locations (1)

100021

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

Sponsors
All Listed Sponsors
lead

Ahon Pharmaceutical Co., Ltd.

OTHER

NCT05439499 - This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. | Biotech Hunter | Biotech Hunter