Consistent with the results of the PALOMA-1 and PALOMA-2 studies, the PALOMA-3 study in 2016 evaluating palbociclib in combination with fulvestrant for the treatment of women with HR-positive/HER2-negative advanced metastatic breast cancer showed that the palbociclib arm had a significantly higher incidence of infection-related AEs compared to the placebo arm (p < 0.02). This evidence concerns the gene ERBB2 and infection.