Manual Review Required

HER2 / ERBB2 expression

solid tumor basket · Small Molecule Inhibitor

HER2 / ERBB2 expression is flagged as manual review required because public trials show inclusion required evidence in 9 contexts. FDA CDx context should be reviewed manually. Threshold text varies across public records.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 6

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 7

Common snippets: KRAS G12C | KRAS G12C | KRAS G12C

Threshold label: Fragmented

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Manual Review Required

CDx maturity score: 2/5

Confidence: Low

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT06126276 | https://clinicaltrials.gov/study/NCT03188965 | https://clinicaltrials.gov/study/NCT03065387 | https://clinicaltrials.gov/study/NCT03994796 | https://clinicaltrials.gov/study/NCT06804824 | https://clinicaltrials.gov/study/NCT06340568 | https://clinicaltrials.gov/study/NCT07142200 | https://clinicaltrials.gov/study/NCT02268747 | https://clinicaltrials.gov/study/NCT00551850