RecruitingNCT06693024

Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer

Sponsor

Shu Wang

Enrollment

2,806 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

HER2-positive Breast Cancer

Summary

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is reviewing patient records to understand how effective neratinib — an oral targeted therapy taken after primary treatment — is in preventing HER2-positive early breast cancer from coming back. HER2-positive breast cancer produces too much of a protein that drives tumor growth, and neratinib is designed to block that protein. **You may be eligible if...** - You have HER2-positive breast cancer diagnosed and treated at Peking University People's Hospital - You underwent surgical removal of the tumor - You received standard anti-HER2 therapy (such as trastuzumab, pertuzumab combined with trastuzumab, or T-DM1) - You have agreed to be part of the hospital's breast cancer research program **You may NOT be eligible if...** - Your medical or pathological records are incomplete - Your cancer has spread to other parts of the body, or you have cancer in both breasts - You did not receive complete surgical removal of the tumor 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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