Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer

Phase 1/2 Terminated 46 enrolled Henan Cancer Hospital

NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study was to evaluate the efficacy and safety of treatment with famitinib plus SHR6390 and endocrine therapy for hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative advanced breast cancer.

Timeline

Start: 2021-12-08
Primary completion: 2024-07-03
Completion: 2024-07-03

Outcome

Mixed primary results

Stopped: “Investigators' decision”

paper Although the objective response threshold in the first stage of phase II was met PMID 42421507 ↗

paper the median PFS did not demonstrate superiority over standard front-line regimens for HR+/HER2- advanced BC PMID 42421507 ↗

Publications

Zhang M, Niu L, Lyu H, Liu Z, Zeng H, Lu Z, Chen X, Qiao J, Yuan P, Zhao S, Sun H, Wang J, Feng Y, Yan M. Addition of angiogenesis inhibitors to CDK4/6 inhibitors and fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer. Chin Med J (Engl). 2026 Jul 7. doi: 10.1097/CM9.0000000000004191. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dalpiciclib	Small molecule	100 mg	Oral
Subject	Famitinib	Small molecule	10 mg	Oral
Subject	Fulvestrant	Small molecule	—	—