Annotation Detail

Information
Associated Genes
ERBB2
Associated Variants
ERBB2 AMPLIFICATION ( ENST00000269571.10 )
ERBB2 AMPLIFICATION ( ENST00000269571.10 )
Associated Disease
Her2-receptor positive breast cancer
Source Database
CIViC Evidence
Description
In this two arm, Phase III study (NCT00878709) of the efficacy of a 12 month course of the TKI neratinib after trastuzumab-based adjuvant therapy of early stage HER2-positive breast cancer was assessed using invasive disease-free survival as primary endpoint. HER2 positivity was assessed via FISH. At 2 year follow-up, 70 vs. 109 disease-free survival events had occurred and disease-free survival rates were 93.9% vs. 91.6% (significant) in neratinib vs. placebo groups respectively. Distant disease-free survival and time to distant recurrence were similar in both groups. These results are an interesting contrast to results of long-term adjuvant therapy with trastuzumab (HERA) which did not show significant benefit.
Variant Origin
somatic
Variant Origin
Somatic
Evidence URL
https://civic.genome.wustl.edu/links/evidence_items/1113
Gene URL
https://civic.genome.wustl.edu/links/genes/20
Variant URL
https://civic.genome.wustl.edu/links/variants/306
Rating
4
Evidence Type
Predictive
Disease
Her2-receptor Positive Breast Cancer
Evidence Direction
Supports
Drug
Trastuzumab,Neratinib
Evidence Level
A
Clinical Significance
Sensitivity/Response
Pubmed
26874901
Drugs
Drug NameSensitivitySupported
NeratinibSensitivitytrue
TrastuzumabSensitivitytrue