Ribociclib plus letrozole for HR-positive HER2-negative breast cancer in male patients

The the phase IIIb CompLEEment-1 trial evaluated the combination of ribociclib and letrozole in patients who had no received prior endocrine therapy and not more than one line of prior chemotherapy for HR-positive HER2-negative advanced breast cancer. The primary analysis was published last year. Analysis of the subgroup of male patients in the trial found that the safety, clinical benefit, and overall response rates among males were consistent with what was seen in the overall population. The median time to progression was not reached with median 25.4 months of follow-up. The authors conclude that this analysis demonstrates the safety and efficacy of the combination for male patients.