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RECRUITING
NCT06234137
NA

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

Sponsor: Wang Ouchen

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2021-11-27

Completion Date

2031-08-01

Last Updated

2024-01-31

Healthy Volunteers

No

Interventions

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

Locations (1)

the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China