NCT04407988

Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer

Phase II Study of Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center clinical study of pyrotinib in combination With letrozole in patients With HER2-Positive, ER-Positive metastatic breast cancer. Our aim was to explore the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive, ER-positive metastatic breast cancer.

Detailed 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 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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib Maleate plus Letrozole	pyrotinib(400 mg once daily) + Letrozole (2.5 mg once daily)

Timeline

• Start date: 2019-11-06
• Primary completion: 2021-12-31
• Completion: 2023-03-31
• First posted: 2020-05-29
• Last updated: 2021-10-13

Locations

1 site across 1 country: China