Manual Review Required

HER2 / ERBB2 amplification

breast cancer · Therapy Not Normalized

HER2 / ERBB2 amplification is flagged as manual review required because public trials show inclusion required evidence in 12 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: 0

Common snippets: None extracted

Threshold label: Low

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/NCT03944499 | https://clinicaltrials.gov/study/NCT01210768 | https://clinicaltrials.gov/study/NCT03387553 | https://clinicaltrials.gov/study/NCT03696030 | https://clinicaltrials.gov/study/NCT03878342 | https://clinicaltrials.gov/study/NCT07233928 | https://clinicaltrials.gov/study/NCT04142554 | https://clinicaltrials.gov/study/NCT01565499 | https://clinicaltrials.gov/study/NCT02365805 | https://clinicaltrials.gov/study/NCT07486089 | https://clinicaltrials.gov/study/NCT02398773 | https://clinicaltrials.gov/study/NCT00073528