Actively Recruiting

All Genders
NCT06693024

Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Led by Shu Wang · Updated on 2024-11-20

2806

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with HER2 positive breast cancer diagnosed by core needle biopsy or operation at Peking University People's Hospital
  • Treated at Peking University People's Hospital and underwent radical resection with hospitalization records
  • Received standard anti-HER2 neoadjuvant or adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
  • Signed and agreed to participate in the PKUPH breast disease cohort study
Not Eligible

You will not qualify if you...

  • Lack of clinical and pathological data such as imaging and pathological results
  • Patients with metastatic breast cancer or bilateral breast cancer
  • Failure to perform radical surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

Y

yuan peng, doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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