NCT04246502

Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine and Pyrotinib	Pyrotinib 400mg orally daily until progressive disease
DRUG	Capecitabine,Trastuzumab, and Pertuzumab	as instruction

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-01
• Completion: 2024-12-01
• First posted: 2020-01-29
• Last updated: 2020-02-05