Trial reportBreast (Edinburgh, Scotland)2020
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.
Trial report in Breast (Edinburgh, Scotland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- CDK4/6 inhibitors combined with fulvestrant for the treatment of HR+/HER2-advanced or metastatic breast cancer: a Bayesian network meta-analysis.BMC cancer · 2026Pooled it
- Impact of CDK4/6 inhibitors on health-related quality of life outcomes in patients with metastatic breast cancer: A systematic review and meta-analysis.Journal of managed care & specialty pharmacy · 2025Pooled it
- Health-related quality of life in breast cancer patients treated with CDK4/6 inhibitors: a systematic review.ESMO open · 2022Pooled it
- Quality of life of therapies for hormone receptor positive advanced/metastatic breast cancer: Regulatory aspects and clinical impact in Europe.Breast (Edinburgh, Scotland) · 2021Pooled it
- Health-Related Quality of Life in Patients with HR+/HER2- Early Breast Cancer Treated with Ribociclib Plus a Nonsteroidal Aromatase Inhibitor: Results from the NATALEE Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- Real-world treatment patterns and sequencing in patients with advanced / metastatic HR+/HER2- breast cancer in Europe and the United States.Breast (Edinburgh, Scotland) · 2026Article
- Guidelines for the Diagnosis and Treatment of Advanced Breast Cancer in China (2024 Edition).Cancer innovation · 2025Article
- Healthcare Resource Utilization and Cost Comparison Between Palbociclib, Abemaciclib, and Ribociclib Among Patients with HR+/HER2- Metastatic Breast Cancer.ClinicoEconomics and outcomes research : CEOR · 2025Article
- Decoding estrogen receptor and GPER biology: structural insights and therapeutic advances in ERα-positive breast cancer.Frontiers in oncology · 2025Review
- Guidelines for diagnosis and treatment of advanced breast cancer in China (2022 edition).Journal of the National Cancer Center · 2024Article
- The Role of CD4/6 Inhibitors in Breast Cancer Treatment.International journal of molecular sciences · 2024Review
- Quality of Life and Treatment-Related Side Effects in Patients With HR+/HER2- Advanced Breast Cancer: Findings From a Multicountry Survey.The oncologist · 2023Article
- CDK4/6 Inhibitors-Overcoming Endocrine Resistance Is the Standard in Patients with Hormone Receptor-Positive Breast Cancer.Cancers · 2023Review
- Quality of life with palbociclib plus fulvestrantTherapeutic advances in medical oncology · 2023Article
- Health-related quality of life and clinical complexity of a real-life cohort of patients with advanced HRDrugs in context · 2023Article
- Quality of life with ribociclibTherapeutic advances in medical oncology · 2023Article
- Cost-Effectiveness and Cost-Utility of Palbociclib versus Ribociclib in Women with Stage IV Breast Cancer: A Real-World Data Evaluation.International journal of environmental research and public health · 2022Article
- The Renaissance of CDK Inhibitors in Breast Cancer Therapy: An Update on Clinical Trials and Therapy Resistance.Cancers · 2022Review
- Psychosocial Aspects of Living Long Term with Advanced Cancer and Ongoing Systemic Treatment: A Scoping Review.Cancers · 2022Article
- Review
Corrections and comments
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Authors and funding
16 authors at 13 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
methodsPatients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
resultsDeterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
conclusionsIn addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.
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