{"entity":{"id":"monaleesa-2","kind":"trial","name":"MONALEESA-2","aka":[],"tldr":"The first CDK4/6 inhibitor trial to show that adding the pill to hormone therapy makes women live longer, by about a year.","summary":"PFS 25.3 vs 16.0 months (HR 0.57); final OS 63.9 vs 51.4 months (HR 0.76, P=0.004), the first OS benefit for a CDK4/6 inhibitor in first-line postmenopausal disease and the longest median OS reported in this setting at the time. With MONALEESA-3 and -7 it established ribociclib as the CDK4/6 inhibitor with the most consistent survival data.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01958021","url":"https://clinicaltrials.gov/study/NCT01958021"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6","estrogen-receptor"],"drugs":["ribociclib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["gabriel-hortobagyi"],"bottlenecks":[],"keyPapers":["paper-monaleesa-2-n-engl-j-med-2016","paper-monaleesa-2-n-engl-j-med-2022-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01958021","phase":"3","setting":"First-line postmenopausal HR+/HER2- advanced breast cancer: ribociclib + letrozole vs placebo + letrozole","sponsor":"Novartis","result":"OS 63.9 vs 51.4 months, HR 0.76.","started":"2013-12-17","startedType":"actual","yearReported":2016,"enrolled":668,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Ribociclib + letrozole","n":334,"value":25.3},{"name":"Placebo + letrozole","n":334,"value":16}],"hr":0.57,"ci":[0.46,0.7],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1609709"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Ribociclib + letrozole","n":334,"value":63.9},{"name":"Placebo + letrozole","n":334,"value":51.4}],"hr":0.76,"ci":[0.63,0.93],"p":"0.004","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2114663"}],"replication":"OS benefit replicated in MONALEESA-7 (premenopausal) and MONALEESA-3 (fulvestrant partner); the class effect on OS was not seen with palbociclib (PALOMA-2)."},"route":"/trials/monaleesa-2/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"}],"target":[{"id":"cdk4-6","kind":"target","name":"CDK4/6","route":"/targets/cdk4-6/"},{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"}],"drug":[{"id":"letrozole","kind":"drug","name":"Letrozole (and other aromatase inhibitors)","route":"/drugs/letrozole/"},{"id":"ribociclib","kind":"drug","name":"Ribociclib","route":"/drugs/ribociclib/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"person":[{"id":"gabriel-hortobagyi","kind":"person","name":"Gabriel N. Hortobagyi","route":"/people/gabriel-hortobagyi/"}],"paper":[{"id":"paper-monaleesa-2-n-engl-j-med-2022-update","kind":"paper","name":"Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer","route":"/key-papers/paper-monaleesa-2-n-engl-j-med-2022-update/"},{"id":"paper-monaleesa-2-n-engl-j-med-2016","kind":"paper","name":"Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer","route":"/key-papers/paper-monaleesa-2-n-engl-j-med-2016/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}