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.

Phase 3 Unknown 312 enrolled Ahon Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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 in combination with fluvestrant ± goseraline in women with HR+ and HER2- advanced breast cancer.

Timeline

Start: 2022-01-18
Primary completion: 2024-02-18
Completion: 2024-05-18

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FCN-437c	Unknown	200 mg	Oral
Background	Fulvestrant	Small molecule	500 mg	Intramuscular
Background	Goserelin	Other / unclassified	3.6 mg	Subcutaneous

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.

Summary

Timeline

Drugs

Indications