Molecular details
Biomarker: BRCA alt
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: Histologically confirmed, newly diagnosed, primary, operable, nonmetastatic invasive breast cancer with the following characteristics:
--ER-negative or ER-low defined as IHC nuclear staining =10%
HER2-negative (not eligible for anti-HER2 therapy) defined as:
IHC 0, 1+ without in situ hybridization OR
In situ hybridization non-amplified with ratio less than 2.0 OR
In situ hybridization average HER2 copy number < 6 signals/cells
Documented deleterious or suspected deleterious mutation in BRCA1 or BRCA2 from local BRCA testing using either a germline or tumour test.
