NCT07470203

Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer

Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 42 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.

Detailed description

The current standard of care for first-line treatment of HER2+ advanced breast cancer consists of induction chemotherapy with a taxane (T) in combination with dual anti-HER2 monoclonal antibody, trastuzumab (H) and pertuzumab (P), followed by maintenance therapy with HP. However, most patients eventually experience disease progression on this regimen and not all will be able to receive a second-line treatment. The aim of this study was to evaluate the efficacy and safety of pyrotinib combined with HP as maintenance therapy for HER2-positive advanced breast cancer patients. The results are expected to provide real-world evidence for optimizing first-line maintenance treatment strategies in patients with HER2+ advanced breast cancer who had completed induction therapy with THP.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	240\~320mg given by mouth (orally) once daily every 21days
DRUG	Trastuzuma	6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
DRUG	Pertuzumab	420mg given by IV every 21 days
DRUG	Combination product: Trastuzumab + Pertuzumab	600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.

Timeline

• Start date: 2026-03-31
• Primary completion: 2029-03-31
• Completion: 2029-09-30
• First posted: 2026-03-13
• Last updated: 2026-03-13