NCT04733417

A Study of SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.

An Exploratory Study of CDK4/6 Inhibitor SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy.

Detailed description

This is a single-center, single-arm, open-label, Simon's two-stage design, phase II clinical trial. The purpose of this study was to evaluate the efficacy and safety of SHR6390 combined with famitinib in the treatment of HR+/HER2 advanced or metastatic breast cancer patients who have progressed during or after 1-2 line endocrine therapy. Subjects will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.

Conditions

• Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR6390	SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
DRUG	famitinib	Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3.

Timeline

• Start date: 2021-05-26
• Primary completion: 2022-08-30
• Completion: 2023-09-30
• First posted: 2021-02-02
• Last updated: 2023-04-13

Locations

1 site across 1 country: China