---
title: "KISQALI + Fulvestrant in Postmenopausal Patients | Kisqali®"
description: "In postmenopausal patients with HR+/HER2– advanced breast cancer, KISQALI + fulvestrant improved median overall survival by 15.8 months vs fulvestrant alone in the MONALEESA-3 trial. Explore the data."
canonical_url: "https://www.kisqali.com/advanced-breast-cancer/efficacy/kisqali-fulvestrant-in-postmenopausal-patients"
meta:
  "og:description": "In postmenopausal patients with HR+/HER2– advanced breast cancer, KISQALI + fulvestrant improved median overall survival by 15.8 months vs fulvestrant alone in the MONALEESA-3 trial. Explore the data."
  "og:title": "KISQALI + Fulvestrant in Postmenopausal Patients"
---

## **KISQALI + Fulvestrant in postmenopausal patients**

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

**1-year increase in mOS with KISQALI + fulvestrant *vs* fulvestrant alone. \*<sup>(1)</sup>**  
 MONALEESA-3: mOS at median 71-month follow-up

*Bar chart illustrating median overall survival (mOS) results from the MONALEESA-3 trial in postmenopausal patients with HR+/HER2– advanced breast cancer at a median follow-up of 71 months. KISQALI + fulvestrant achieved a median OS of 67.6 months versus 51.8 months with fulvestrant alone, representing a 15.8-month improvement in mOS.*

67.6 months

KISQALI + FUL

51.8 months

FUL alone

15.8-month

mOS increase\*

\* HR 0.673; 95% CI: 0.504–0.899. <sup>(1)</sup>

### **MONALEESA-3 study design**

![Portrait of a smilling Middle Eastern  postmenopausal woman representing the MONALEESA-3 advanced breast cancer clinical trial.](https://www.kisqali.com/img/advanced-breast-cancer/mobile/efficacy-monaleesa-3-study-woman-portrait.webp)

**MONALEESA-3:** N=726, double-blind, placebo-controlled, 2:1 randomised, phase III trial. As 1L and 2L in advanced disease plus those with early relapse in postmenopausal women with HR+/HER2– ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR, CBR, and safety and tolerability.  
  
 1L defined as: newly diagnosed (de novo) ABC patients or patients with relapse >12 months from completion of (neo)adjuvant ET with no treatment for ABC or metastatic disease.  
  
 2L was defined as: relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced or metastatic disease (early relapse); relapse >12 months from completion of (neo)adjuvant therapy with subsequent progression after one line of endocrine therapy for advanced or metastatic disease, and advanced or metastatic breast cancer at diagnosis that progressed after one line of endocrine therapy for advanced disease with no prior (neo)adjuvant treatment for early disease. <sup>(2)</sup>

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