MONALEESA-3 PRO Analysis: Ribociclib + Fulvestrant

Source

Source: Fasching PA et al. The Breast. 2020;54:148-154. This study reports patient-reported outcomes from the MONALEESA-3 trial.

Quality of Life Data · Fasching et al., 2020 · Advanced Breast Cancer (HR+/HER2-)

Study Design

Phase III Randomized (2:1)
Postmenopausal, N=726

Ribociclib + Fulvestrant
(n=484)

Placebo + Fulvestrant
(n=242)

0.81

Hazard Ratio (GHS)

19% reduction in risk of health deterioration vs. placebo.

Outcome Highlights

Global Health: Median TTD extended to 35.9 months (vs 33.1).
Pain Control: HR 0.77 favoring Ribociclib arm.
Physical Function: HR 0.82 showing preservation of capability.

Median Time to Deterioration

Global Health Status (Months, Higher is Better)

Risk of Deterioration (HR)

Values < 1.0 favor Ribociclib Combination

Recommendation: Prioritize Ribociclib + Fulvestrant

This combination offers a "high-value" treatment strategy. It significantly improves survival (PFS/OS) without accelerating physical decline or increasing pain burden compared to endocrine monotherapy.

AbbreviationsQuick

BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire; FUL, fulvestrant; GHS, global health status; HER2–, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQOL, health-related quality of life; LSM, least squares mean; OS, overall survival; PBO, placebo; PFS, progression-free survival; PRO, patient-reported outcome; RIB, ribociclib; SEM, standard error of the mean; TTD, time to definitive deterioration.

Bibliography3

Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. The Breast. 2020;54:148-154. (DOI: 10.1016/j.breast.2020.09.008 | link)
Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514-524. (DOI: 10.1056/NEJMoa1911149)
Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-2472. (DOI: 10.1200/JCO.2018.78.9909)