Manual Review Required

BRCA1/2 mutation

breast cancer · Small Molecule Inhibitor

BRCA1/2 mutation is flagged as manual review required because public trials show inclusion required evidence in 8 contexts. FDA CDx context should be reviewed manually.

Role evidence

Usage summary

Strongest role: Inclusion Required

Inclusion-required count: 4

Treatment-assignment count: 0

Stratification count: 0

Threshold snippets

Fragmentation view

Threshold count: 2

Common snippets: dMMR | MSI-H

Threshold label: Moderate

FDA CDx context

Mapping summary

CDx label: Fda Cdx Context Not Found

CDx maturity score: 1/5

Confidence: Low

Patent-density signal

Diagnostic appendix

Signal count: 0

Recent signals: 0

Density label: Low

Source links

Evidence paths

https://clinicaltrials.gov/study/NCT02326844 | https://clinicaltrials.gov/study/NCT01989546 | https://clinicaltrials.gov/study/NCT04090567 | https://clinicaltrials.gov/study/NCT03562832 | https://clinicaltrials.gov/study/NCT02163694 | https://clinicaltrials.gov/study/NCT02401347 | https://clinicaltrials.gov/study/NCT05378204 | https://clinicaltrials.gov/study/NCT06625515