NCT06234137

A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Wang Ouchen · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.

Conditions

• Breast Neoplasm Female

Interventions

Type	Name	Description
DRUG	Docetaxel	75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
DRUG	Carboplatin	AUC=6 min/mL iv 3-weekly
DRUG	Inetetamab	8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
DRUG	Pyrotinib	400mg orally daily

Timeline

• Start date: 2021-11-27
• Primary completion: 2025-07-31
• Completion: 2031-08-01
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: China