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
This Phase II trial (LUX-Breast 3 - NCT01441596) compared afatinib, afatinib plus vinorelbine, or investigator's choice of treatment. 121 patients with HER2 overexpressing breast cancer with CNS recurrence or regression who had previously progressed on trastuzumab or lapatinib were assigned to 3 arms, with endpoint in the intention-to-treat population being patient benefit at 12 weeks defined as absence of CNS or extra CNS progression, no tumor related worsening of neurological symptoms and no increase in corticosteroid dose. Benefit was seen in 30% of 40 patients assigned to afatinib alone, 34.2% of 38 assigned to afatinib plus vinorelbine, and 41.9% of 43 assigned to investigator's treatment choice. Differences were not statistically significant, and afatanib patients experienced more adverse effects. While Afatanib did show response in HER2 breast cancer patients, it was not better than investigator's treatment choice and the investigators state that no further development of afatinib for HER2 breast cancer will be planned.
Variant Origin
somatic
Variant Origin
Somatic
Evidence URL
https://civic.genome.wustl.edu/links/evidence_items/1011
Gene URL
https://civic.genome.wustl.edu/links/genes/20
Variant URL
https://civic.genome.wustl.edu/links/variants/306
Rating
3
Evidence Type
Predictive
Disease
Her2-receptor Positive Breast Cancer
Evidence Direction
Supports
Drug
Afatinib
Evidence Level
B
Clinical Significance
Sensitivity/Response
Pubmed
26596672
Drugs
Drug NameSensitivitySupported
AfatinibSensitivitytrue