The high ORR of 62.6% with talazoparib vs. control ORR of 27.2% in the phase III EMBARCA trial (NCT01945775) led to the FDA approval of the inhibitor for locally-advanced or metastatic HER2-negative breast cancer with germline mutations in BRCA1/2 (43). This evidence concerns the gene ERBB2 and breast carcinoma.