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Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
Sponsor: Shu Wang
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.
Official title: A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2806
Start Date
2019-01-01
Completion Date
2031-12-31
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
neratinib
neratinib 240mg qd for 1 year
Locations (1)
Peking University People's Hospital
Beijing, Beijing Municipality, China