--- title: "KISQALI + AI in Premenopausal Patients | Kisqali®" description: "In premenopausal patients with HR+/HER2– advanced breast cancer, KISQALI + aromatase inhibitor improved median overall survival to 58.7 months vs 47.7 months with AI alone in MONALEESA-7 trial. Explore the data." canonical_url: "https://www.kisqali.com/advanced-breast-cancer/efficacy/kisqali-ai-in-premenopausal-patients" meta: "og:description": "In premenopausal patients with HR+/HER2– advanced breast cancer, KISQALI + aromatase inhibitor improved median overall survival to 58.7 months vs 47.7 months with AI alone in MONALEESA-7 trial. Explore the data." "og:title": "KISQALI + AI in Premenopausal Patients" --- ## **KISQALI + AI in premenopausal patients** ### **1L in premenopausal patients: KISQALI the first and only CDK4/6i to achieve 5-year mOS. **(1) MONALEESA-7: mOS at median 54-month follow-up: \*(1) *Bar chart illustrating median overall survival (mOS) results from the MONALEESA-7 trial in pre/perimenopausal patients with HR+/HER2– advanced breast cancer at a median follow-up of 54 months. KISQALI + aromatase inhibitor achieved a median OS of 58.7 months versus 47.7 months with aromatase inhibitor alone.* 58.7 months † KISQALI + AI 47.7 months AI alone \*Results from the 54-month analysis were not prespecified and were observational in nature, as such, there was no prespecified statistical procedure controlling for type 1 error. (1,2) † HR 0.80; 95% CI: 0.62–1.04. (1) ### **MONALEESA-7 study design** ![Portrait of a smiling asian premenopausal woman used for MONALEESA-7 breast cancer study design.](https://www.kisqali.com/img/advanced-breast-cancer/mobile/efficacy-monaleesa-7-study-woman-portrait.webp) **MONALEESA-7:** N=672, double-blind, placebo-controlled, 1:1 randomised, phase III trial in pre- or perimenopausal women with HR+/HER2− ABC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for ABC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen\* 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle). The primary endpoint was investigatorassessed PFS. The key secondary endpoint was OS, defined as the time from randomisation to death from any cause. (1) \* KISQALI should not be co-administered with tamoxifen. (3) ## Sitemap See the full [sitemap](/sitemap.md) for all pages.