# MONALEESA-2

Source: https://onco.cc/trials/monaleesa-2/  
OnCo record `monaleesa-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01958021
- Phase: 3
- Setting: First-line postmenopausal HR+/HER2- advanced breast cancer: ribociclib + letrozole vs placebo + letrozole
- Sponsor: Novartis
- Enrolled: 668
- Result: OS 63.9 vs 51.4 months, HR 0.76.
- Outcomes: Progression-free survival: Ribociclib + letrozole 25.3 months vs Placebo + letrozole 16 months, HR 0.57; Overall survival: Ribociclib + letrozole 63.9 months vs Placebo + letrozole 51.4 months, HR 0.76
- 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).

## Sources

- ClinicalTrials.gov NCT01958021: https://clinicaltrials.gov/study/NCT01958021

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [CDK4/6 inhibitors](https://onco.cc/technologies/cdk46-inhibitor/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/), [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/)
- drugs: [Letrozole (and other aromatase inhibitors)](https://onco.cc/drugs/letrozole/), [Ribociclib](https://onco.cc/drugs/ribociclib/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- people: [Gabriel N. Hortobagyi](https://onco.cc/people/gabriel-hortobagyi/)
- key papers: [Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer](https://onco.cc/key-papers/paper-monaleesa-2-n-engl-j-med-2022-update/), [Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer](https://onco.cc/key-papers/paper-monaleesa-2-n-engl-j-med-2016/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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