At a glance
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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
In Brief
A Phase 3 clinical trial evaluating FCN-437c, Letrozole or anastrozole, Goserelin acetate and Placebo, Letrozole or anastrozole, Goserelin acetate for Advanced Breast Cancer and Female Breast Cancer. Targeting 434 participants across 1 site.
Detailed 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-.
Study Details
Timeline
Interventions
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。
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。