---
title: "KISQALI + AI in Postmenopausal Patients | Kisqali®"
description: "In postmenopausal patients with HR+/HER2– advanced breast cancer, KISQALI + aromatase inhibitor improved median overall survival by 12.5 months vs AI alone in the MONALEESA-2 trial. Explore the data."
canonical_url: "https://www.kisqali.com/advanced-breast-cancer/efficacy/kisqali-ai-in-postmenopausal-patients"
meta:
  "og:description": "In postmenopausal patients with HR+/HER2– advanced breast cancer, KISQALI + aromatase inhibitor improved median overall survival by 12.5 months vs AI alone in the MONALEESA-2 trial. Explore the data."
  "og:title": "KISQALI + AI in Postmenopausal Patients"
---

## **KISQALI + AI in postmenopausal patients**

### **1L in postmenopausal patients: KISQALI + AI significantly increased mOS benefit ***vs*** AI alone. **<sup>(1)</sup>

**1-year increase in mOS with KISQALI + AI *vs* AI alone. \*<sup>(1)</sup>**  
 MONALEESA-2: mOS at median 80-month follow-up

*Median overall survival in MONALEESA-2: KISQALI + AI vs AI alone*

63.9 months

KISQALI + AI + goserelin

51.4 months

AI alone

12.5-month

mOS increase<sup>†</sup>

\* HR 0.76; 95% CI: 0.63–0.93; p=0.008. <sup>(1)</sup>

### **MONALEESA-2 study design**

![Portrait of a smilling  black postmenopausal woman representing the MONALEESA-2 breast cancer study design.](https://www.kisqali.com/img/advanced-breast-cancer/mobile/efficacy-monaleesa-2-study-woman-portrait.webp)

**MONALEESA-2:** N=668, double-blind, placebo-controlled, 1:1 randomised, multicentre, phase III trial in postmenopausal women with HR+/HER2− ABC. As 1L in advanced disease.  
  
 No prior endocrine therapy for ABC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous).  
  
 The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QOL assessments. <sup>(2)</sup>

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