RecruitingPhase 2NCT04481932

Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer

Trastuzumab Combined With Pyrotinib and Chemotherapy for Locally Advanced, Inflammatory, or Early HER2-positive Mammary glandsCancer: One Arm, Open, Phase II Clinical Study

Sponsor

Peking University

Enrollment

104 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate (pCR) for adenocarcinoma.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the drug pyrrolidine to the standard combination of trastuzumab (Herceptin) and chemotherapy improves outcomes for women with HER2-positive breast cancer before surgery (neoadjuvant treatment). HER2-positive means the tumor has too much of a protein that makes it grow faster. **You may be eligible if...** - You are a woman aged 18–70 - You have been confirmed by biopsy to have invasive breast cancer that is HER2-positive - Your primary tumor is larger than 2cm - Your cancer has not spread to distant organs - You have not received any prior cancer treatment for this diagnosis - Your heart function is adequate **You may NOT be eligible if...** - You have previously received chemotherapy, radiation, or targeted therapy for this cancer - You are pregnant or breastfeeding - You have significant heart problems 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

DRUGTrastuzumab combined with Pyrotinib and chemotherapy

Pyrotinib is a small molecule, irreversible tyrosine kinase inhibitor with targets of epidermal growth factor receptor 1 (EGFR/HER1/ErbB1), human epidermal factor receptor 2 (HER2/ErbB2/Neu) and human epidermis Factor Receptor 4 (HER4/ErbB4). As a new generation of anti-HER2 therapeutic targeted drugs, pirotinib covalently binds to the ATP binding sites of the kinase regions of EGFR, HER2 and HER4 in cells to prevent homogeneity and heterogeneity of EGFR, HER2 and HER4 in tumor cells Dimer formation, inhibiting its own phosphorylation, blocking the activation of downstream signaling pathways, thereby inhibiting tumor cell growth