NCT06133088

Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.

Explore the Efficacy and Safety of Dalpiciclib Combined With Fluvestrant and Compound Gossypol Acetate Tablets in Advanced HR-positive and HER2-negative Breast Cancer After CDK4/6 Treatment Failed.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6 treatment failed.

Detailed description

Dalpiciclib: According to the standard dose, 150mg orally for three weeks and stop for one week. Fluvestrant: At the standard dose, 500mg once every four weeks. A further 500mg dose two weeks after the first dose. Compound gossypol acetate tablets: 20mg once a day.

Conditions

• Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed

Interventions

Type	Name	Description
DRUG	dalpiciclib; fluvestrant; compound gossypol acetate tablets	Darcilie: 150mg orally for three weeks and stop for one week. Fluvestrant: 500mg every four weeks. A further 500mg dose two weeks after the first dose. Compound gossyrol acetate tablet: 20mg daily.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-12-31
• Completion: 2025-08-31
• First posted: 2023-11-15
• Last updated: 2023-11-15

Locations

1 site across 1 country: China