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.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR-positive and HER2-negative Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 434 (estimated)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 letrozole or anastrozole ± Goserelin versus placebo combined with letrozole or anastrozole ± Goserelin in women with first-line advanced breast cancer in HR+ and HER2-.

Conditions

• Advanced Breast Cancer
• Female Breast Cancer

Interventions

Type	Name	Description
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。

Timeline

• Start date: 2022-03-02
• Primary completion: 2024-09-20
• Completion: 2025-03-02
• First posted: 2022-06-30
• Last updated: 2022-07-06

Locations

1 site across 1 country: China