The CompLEEment-1 trial is one of the largest trials in advanced breast cancer. The phase IIIb trial investigated the safety and efficacy of ribociclib plus letrozole in 3,255 patients. The preliminary results of the first 1,000 patients were presented at ASCO 2018; at ESMO 2018, the results from the subgroup of 39 men were presented. We caught up with Dr Claudio Zamagni at the ESMO Congress to learn more about these results. The subgroup results reveal that the combination of ribociclib and letrozole is well tolerated, and tolerability between males and females was not significantly different. We are still waiting for the results from the full CompLEEment-1 population, but these early data show promise in the treatment of advanced breast cancer for both men and women.
Questions:
1. What was the background and rationale behind the CompLEEment-1 trial? (0:11)
2. What were the key outcomes and findings from the trial? And what were the findings from the subgroup of men, that you are presenting at this year’s ESMO Congress? (1:15)
3. What are the next steps in this area of research over the coming years? (2:45)
4. What will this mean for clinical practice in the future, particularly for male patients? (4:19)
Speaker disclosures: Claudio Zamagni has nothing to disclose in relation to this interview.
Filmed at the European Society for Medical Oncology (ESMO) 2018 Congress, Munich, Germany, 19–23 October 2018.
