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Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

NCT06693024 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2806

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

neratinib

neratinib 240mg qd for 1 year

Sponsors & Collaborators

  • Shu Wang

    lead OTHER

Principal Investigators

  • shu wang, doctor · Peking University People's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693024 on ClinicalTrials.gov