RecruitingNot ApplicableNCT06234137

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

Enrollment

154 participants

Start Date

Nov 27, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasm Female

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of chemotherapy (docetaxel and carboplatin) with two targeted anti-HER2 drugs (inetetamab and pyrotinib) as treatment before surgery for women with locally advanced HER2-positive breast cancer. **You may be eligible if...** - You are a female between 18 and 75 years old - You have locally advanced breast cancer that is HER2-positive (confirmed by tissue test) - Your tumor is larger than 2 cm - Your hormone receptor status (ER/PR) is known - Your heart, blood counts, liver, and kidneys are functioning within normal range **You may NOT be eligible if...** - You have already received any breast cancer treatment - You have significant heart problems (heart function below 60%) - You are pregnant or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel

75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

DRUGCarboplatin

AUC=6 min/mL iv 3-weekly

DRUGInetetamab

8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

DRUGPyrotinib

400mg orally daily

Locations(1)

the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT06234137

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