Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
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.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
6 citing papers in PubMed.
- Austrian treatment algorithms 2025: CDK 4/6 inhibitors in the adjuvant therapy of HR+/HER2- early breast cancer.Wiener klinische Wochenschrift · 2026Review
- Risk of Recurrence in Patients with HR+/HER2- Early Breast Cancer: A Podcast.Targeted oncology · 2026Article
- Review
- Patient-reported outcomes of adjuvant therapy with CDK4/6 inhibitors for HR+/HER2- early breast cancer: a retrospective cohort study.BMC cancer · 2026Observational
- Eligibility for adjuvant CDK4/6 inhibitors in HR+/HER2- early breast cancer: insights from a large cohort in central south China.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026Article
- New Therapeutic Scenarios in the Context of Adjuvant Treatment for HR+/HER2-Breast Cancer: The Possible Role of Ribociclib in Treatment Algorithms for Stage II and III.Current oncology (Toronto, Ont.) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
purposeThe phase III NATALEE trial reported a statistically significant invasive disease-free survival benefit with ribociclib plus nonsteroidal aromatase inhibitor (NSAI) versus an NSAI alone in stage II/III hormone receptor-positive, HER2-negative (HR+/HER2-) early breast cancer. In this study, we report health-related quality of life (HRQOL) data from NATALEE. PATIENTS AND
methodsPatients were randomized to receive ribociclib plus NSAI or NSAI alone. Patient-reported outcome scores [European Organisation for Research and Treatment of Cancer core quality of life questionnaire global health status and physical, social, and emotional functioning domains; the supplementary European Organisation for Research and Treatment of Cancer breast cancer-specific QOL questionnaire breast symptoms scale; health on a visual analog scale of the generic EuroQOL 5-level instrument; and the Hospital Anxiety and Depression Scale] were assessed. The prespecified primary HRQOL endpoint was physical functioning. Mean scores and time-categorical and prespecified linear-time repeated-measure models were used to evaluate HRQOL changes during treatment.
resultsHRQOL was evaluated in all patients in the ribociclib plus NSAI (n = 2,549) and NSAI alone (n = 2,552) arms. Compliance was high in both arms (≈93%-97%). Mean scores did not differ meaningfully from baseline for any analyzed domain. Likewise, neither a meaningful change from baseline (in either treatment arm) nor a difference between arms was observed during treatment in the time-categorical, model-adjusted mean scores for any HRQOL domains-using published thresholds for interpreting longitudinal and between-group differences, with all values being within 0.5 SD of their baseline values. Linear-time regression analysis confirmed these findings.
conclusionsThese analyses of NATALEE show that adding adjuvant ribociclib to an NSAI does not negatively affect HRQOL in patients with HR+/HER2- early breast cancer.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.