- Have histologically confirmed adenocarcinoma of the breast that is either TNBC or HR positive/HER-2 negative. TNBC is defined as: ER/PR <1% and HER-2 negative disease (IHC 0-1+ or 2+ with HER2/17 ratio on FISH ≤1.8) according to ASCO/CAP guidelines11,67. HR positive is defined as: ER/PR >= 1% and HER-2 negative as per ASCO/CAP guidelines.