Role evidence
Usage summary
Strongest role: Inclusion Required
Inclusion-required count: 10
Treatment-assignment count: 0
Stratification count: 1
Manual Review Required
HER2 / ERBB2 amplification
breast cancer · Monoclonal Antibody
HER2 / ERBB2 amplification is flagged as manual review required because public trials show inclusion required evidence in 16 contexts. FDA CDx context exists.
Threshold snippets
Fragmentation view
Threshold count: 3
Common snippets: HER2-low | HER2-low | HER2-low
Threshold label: Moderate
FDA CDx context
Mapping summary
CDx label: Fda Cdx Context Exists
CDx maturity score: 5/5
Confidence: Low
Patent-density signal
Diagnostic appendix
Signal count: 0
Recent signals: 0
Density label: Low
Source links
Evidence paths
https://clinicaltrials.gov/study/NCT01285466 | https://clinicaltrials.gov/study/NCT04704661 | https://clinicaltrials.gov/study/NCT03321981 | https://clinicaltrials.gov/study/NCT00493649 | https://clinicaltrials.gov/study/NCT05795101 | https://clinicaltrials.gov/study/NCT01779050 | https://clinicaltrials.gov/study/NCT05919212 | https://clinicaltrials.gov/study/NCT04699630 | https://clinicaltrials.gov/study/NCT03304080 | https://clinicaltrials.gov/study/NCT04301375 | https://clinicaltrials.gov/study/NCT04578106 | https://clinicaltrials.gov/study/NCT01832051 | https://clinicaltrials.gov/study/NCT03144947 | https://clinicaltrials.gov/study/NCT00320411 | https://clinicaltrials.gov/study/NCT01306942 | https://clinicaltrials.gov/study/NCT01688609