A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

Summary

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.

Timeline

Start

2022-05-25

Primary completion

2023-12-31

Completion

2025-07-31

Publications

• Tao Z, Zhang J, Zheng Q, Wang Y, Cai L, Xu H, Xu X, Kong X, Ding S, Hao C, Wang H, Zong H, Jin X, Wang X, Li Y, Yang X, Li W, Du X, Chen H, Wu P, Li P, Mao L, Ding L, Hu X, Wang S. Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1055-1063. doi: 10.1001/jamaoncol.2025.2092.
• Zhang J, Liu R, Gao S, Chen W, Han X, Wang Z, Zhou H, Wang Y, Chen J, Ma Y, Liu K, Shen Z, Ding L, Li P, Hu X. A phase I dose-escalation and dose-expansion study of tibremciclib, a novel CDK4/6 inhibitor, monotherapy and in combination with fulvestrant in HR-positive/HER2-negative advanced breast cancer. ESMO Open. 2025 Jun;10(6):105121. doi: 10.1016/j.esmoop.2025.105121. Epub 2025 May 21.

Drugs

Indications