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Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Study acronym: NeraHER2
StatusRecruiting
PhaseNot specified
SponsorShu Wang
Started2019-01-01
View on ClinicalTrials.gov ↗

Amendment history

2024-11-17
minor
Study Status, Study Description v1
Study description+66 characters
WeInvestigators retrospectively recuited patients with early HER2 positive breast cancer treated in ourPeking University People's Hospital center from January 1, 2019 to November 31, 2024, and prosp [...] University People's hospital; The patients were treated in ourPeking hospitalUniversity People's Hospital and underwent radical resection with hospitalization record [...]
2024-11-14
minor
Original filing
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.
Trial Details
NCT Number NCT06693024
Lead Sponsor Shu Wang
Conditions HER2-positive Breast Cancer
Enrollment 2,806 participants
Start Date 2019-01-01
Primary Completion 2031-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-20