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.

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-.

Timeline

Start

2022-03-02

Primary completion

2024-09-20

Completion

2025-03-02

Publications

• Yuan P, Liu Y, Li W, Li H, Tong Z, Cheng J, Zhang M, Shan J, Zhong J, Yi T, Liu J, Li H, Huang Z, Wu J, Ding S, Li L, Zong H, Jia H, Wang S, Wang K, Guo H, Ma L, Ouyang Z, Li H, Sun T, Lu P, Yang X, Wang X, Peng Y, Li L, Xu B; FCN-437c-III201 Investigators. Fovinaciclib for First-Line Therapy of Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2026 Jun 1:e261938. doi: 10.1001/jamaoncol.2026.1938. Online ahead of print.

Drugs

Indications