Role evidence
Usage summary
Strongest role: Inclusion Required
Inclusion-required count: 4
Treatment-assignment count: 1
Stratification count: 0
Drug Development Ahead Of Cdx Context
HER2 / ERBB2 amplification
solid tumor basket · Monoclonal Antibody
HER2 / ERBB2 amplification is flagged as drug development ahead of cdx context because public trials show inclusion required evidence in 6 contexts. FDA CDx context should be reviewed manually.
Threshold snippets
Fragmentation view
Threshold count: 3
Common snippets: dMMR | BRAF V600E | BRAF V600E
Threshold label: Moderate
FDA CDx context
Mapping summary
CDx label: Fda Cdx Context Manual Review Required
CDx maturity score: 2/5
Confidence: Medium
Patent-density signal
Diagnostic appendix
Signal count: 0
Recent signals: 0
Density label: Low
Source links
Evidence paths
https://clinicaltrials.gov/study/NCT00042809 | https://clinicaltrials.gov/study/NCT05256225 | https://clinicaltrials.gov/study/NCT02213289 | https://clinicaltrials.gov/study/NCT02693535 | https://clinicaltrials.gov/study/NCT04551521 | https://clinicaltrials.gov/study/NCT05980416