NCT05560308

Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.

Conditions

• HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy

Interventions

Type	Name	Description
DRUG	Trastuzumab Emtansine for Injection	3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle;
DRUG	Pyrotinib Maleate Tablets	The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle;

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-08-31
• Completion: 2025-08-23
• First posted: 2022-09-29
• Last updated: 2022-10-03