MONALEESA2

MONALEESA2 was a clinical trial that investigated the efficacy and safety of ribociclib in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The primary endpoint of the trial was progression-free survival. Patients in the study were randomly assigned to receive either ribociclib plus letrozole or a placebo plus letrozole.

The trial enrolled a significant number of participants and demonstrated a statistically significant improvement in progression-free survival for the group receiving ribociclib. This meant that patients treated with the combination therapy experienced a longer period before their cancer progressed compared to those receiving the placebo. The safety profile of ribociclib in combination with letrozole was also evaluated, with common adverse events including neutropenia, nausea, fatigue, and diarrhea.

The results of MONALEESA2 were considered a major advancement in the treatment of this specific type of breast cancer. They provided strong evidence supporting the use of ribociclib as a standard of care option in combination with endocrine therapy for postmenopausal women with advanced or metastatic HR+/HER2- breast cancer. This trial contributed to the regulatory approval of ribociclib in many countries for this indication.