NCT04095390

A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer

A Phase Ⅱ Trial Program Exploring The Integration Of Novel HER2-targeted Tyrosine Kinase Inhibitor Pyrotinib and CDK4/6 Inhibitor SHR6390 Into Current Chemotherapy/Endocrine Therapy Regimes For Prior Trastuzumab-treated Advanced HER2-positive Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jinming Yu · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of pyrotinib combination with CDK4/6 Inhibitor SHR6390 in advanced HER2-Positive breast cancer patients who prior trastuzumab-treated.

Conditions

• Metastatic Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	400 mg
DRUG	SHR6390	125mg
DRUG	Letrozole	2.5mg
DRUG	Capecitabine	500mg

Timeline

• Start date: 2019-09-30
• Primary completion: 2021-11-30
• Completion: 2022-08-30
• First posted: 2019-09-19
• Last updated: 2019-09-19

Locations

1 site across 1 country: China