Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Metastatic Breast Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pyrotinib plus LetrozoleMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

ER+/HER2+ metastatic breast cancer is a special subtype of HER2+ breast cancer. General guidelines recommend chemotherapy combined with HER2-targeted therapy for this subtype of patients. However, for the highly selected patients with ER- positive/HER2-positive ABC, ET + anti-HER2 therapy could be c...

ER+/HER2+ metastatic breast cancer is a special subtype of HER2+ breast cancer. General guidelines recommend chemotherapy combined with HER2-targeted therapy for this subtype of patients. However, for the highly selected patients with ER- positive/HER2-positive ABC, ET + anti-HER2 therapy could be chosen as first-line therapy. And Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Therefore this study is planned to enroll 86 patients with HER2-positive, ER-positive metastatic breast cancer receiving first-line treatment with pyrotinib and letrozole. The main purpose was to evaluate the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive, ER-positive metastatic breast cancer.

Tracking Information

NCT #
NCT04407988
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Quchang Ouyang, PhD Department of Breast Cancer Medical Oncology