Evidence map›Paper›PMID 41320342›Full record

Trial reportESMO open2025

Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival.

J Crown, D Stroyakovskii, D A Yardley, C-S Huang, P A Fasching, A Bardia, S Chia, S-A Im, M Martin, B Xu and 12 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Economic value of ribociclib in early breast cancer in the United States.Journal of managed care & specialty pharmacy · 2026
    Article
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  14. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

J CrownSt. Vincent's University Hospital, Dublin, Ireland. Electronic address: john.crown@ccrt.ie.
D StroyakovskiiMoscow City Oncology Hospital #62 of Moscow Healthcare Department, Moscow, Russia.
D A YardleySarah Cannon Research Institute, Nashville, USA.
C-S HuangNational Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
P A FaschingUniversity Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
A BardiaDavid Geffen School of Medicine at UCLA, Los Angeles, USA; The UCLA Health Jonsson Comprehensive Cancer Center, Los Angeles, USA.
S ChiaBC Cancer, Vancouver, Canada.
S-A ImCancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
M MartinInstituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid, Spain.
B XuNational Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
C H BarriosLatin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.
M UntchInterdisciplinary Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin, Germany.
R MorooseOrlando Health Cancer Institute, Orlando, USA.
S A HurvitzUniversity of Washington, Fred Hutchinson Cancer Center, Seattle, USA.
G N HortobagyiDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
D J SlamonDavid Geffen School of Medicine at UCLA, Los Angeles, USA.
F ViscoNational Breast Cancer Coalition (NBCC), Washington, USA.
G SperaTranslational Research in Oncology (TRIO), Montevideo, Uruguay.
J P ZarateNovartis Pharmaceuticals Corporation, East Hanover, USA.
D HalliganNovartis Ireland Ltd, Dublin, Ireland.
Z LiNovartis Pharmaceuticals Corporation, East Hanover, USA.
S LoiPeter MacCallum Cancer Centre, Melbourne, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAt the primary efficacy analysis of the NATALEE phase III trial, ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) demonstrated a statistically significant improvement in invasive disease-free survival (iDFS) versus NSAI alone in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC). Continued follow-up of efficacy outcomes is important in assessing the durability of treatment benefit. We report 5-year estimates of efficacy outcomes, including an udpated analysis of overall survival (OS). PATIENTS AND

methodsEligible patients included pre/postmenopausal women and men with HR-positive/HER2-negative EBC and anatomic stage IIA (N1 or N0 with high-risk factors), IIB, or III disease. Patients were randomized 1 : 1 to ribociclib 400 mg/day (3 weeks on/1 week off for 3 years) + NSAI (letrozole 2.5 mg/day or anastrozole 1 mg/day for 5 years) or NSAI alone. Premenopausal women and men received goserelin. The primary endpoint was iDFS, and secondary/exploratory endpoints included distant disease-free survival, recurrence-free survival, distant recurrence-free survival, and OS.

resultsWith a median iDFS follow-up of 55.4 months, ribociclib + NSAI demonstrated persistent iDFS benefit versus NSAI alone [hazard ratio 0.716, 95% confidence interval (CI) 0.618-0.829, nominal one-sided log-rank P < 0.0001]. Absolute iDFS improvement between treatment arms increased from the 3- (Δ2.7%) to the 5-year (Δ4.5%) time points. Persistent benefit over time was also observed across subgroups [including N0 patients (hazard ratio 0.606, 95% CI 0.372-0.986)] and secondary/exploratory endpoints. As OS continues to mature, numerical improvement in favor of ribociclib was observed (hazard ratio 0.800, 95% CI 0.637-1.003, nominal one-sided log-rank P = 0.026).

conclusionsThis prespecified 5-year follow-up of efficacy outcomes from NATALEE demonstrated that ribociclib + NSAI continued to reduce the risk of recurrence beyond the 3-year treatment window, supporting its use as adjuvant therapy in patients with HR-positive/HER2-negative EBC. An ongoing positive trend for improved OS in favor of ribociclib + NSAI was observed.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsPurinesAdultAgedChemotherapy, AdjuvantErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansLetrozoleMaleMiddle AgedReceptors, EstrogenAminopyridinesAromatase InhibitorsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozolePurinesReceptors, EstrogenReceptors, ProgesteroneribociclibCDK4/6 inhibitorearly breast cancerHR positive/HER2 negativeNATALEEribociclib

Identifiers

PMID41320342
PMCPMC12684762

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.