Manual Review Required

HER2 / ERBB2 expression

breast cancer · Immune Checkpoint Inhibitor

HER2 / ERBB2 expression is flagged as manual review required because public trials show inclusion required evidence in 11 contexts. FDA CDx context exists.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 9

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 3

Common snippets: HER2-low | MSI-H | MSI-H

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/NCT07287917 | https://clinicaltrials.gov/study/NCT01848834 | https://clinicaltrials.gov/study/NCT07054242 | https://clinicaltrials.gov/study/NCT03515798 | https://clinicaltrials.gov/study/NCT02990845 | https://clinicaltrials.gov/study/NCT05163223 | https://clinicaltrials.gov/study/NCT03222856 | https://clinicaltrials.gov/study/NCT07486687 | https://clinicaltrials.gov/study/NCT07003009 | https://clinicaltrials.gov/study/NCT04787042 | https://clinicaltrials.gov/study/NCT03492918