Evidence map›Paper›PMID 37653397›Full record

Trial reportBreast cancer research : BCR2023

Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant.

P Neven, P A Fasching, S Chia, G Jerusalem, M De Laurentiis, S-A Im, K Petrakova, G V Bianchi, M Martín, A Nusch and 8 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research : BCR, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02422615 (A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment), which is not on this map. Cited by 65 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 10 pooled it
17.1field-weighted citation impact, top 1% of its field
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.

NCT02422615 phase3completednot on this map

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2023Enrolled726ConditionsAdvanced Breast CancerArmsRibociclib, Fulvestrant, Placebo
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 10 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Observational
  12. Article
  13. Economic value of ribociclib in early breast cancer in the United States.Journal of managed care & specialty pharmacy · 2026
    Article
  14. Review
  15. Targeting Estrogen Receptor for Breast Cancer.Current issues in molecular biology · 2026
    Review
  16. Review
  17. Review
  18. Observational
  19. Review
  20. Observational

5 more citing papers are in PubMed but not listed here.

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

18 authors at 15 institutions in 10 countries.

P NevenMultidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Herestraat 49, 3000, Leuven, Belgium. patrick.neven@uzleuven.be.
P A FaschingUniversity Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
S ChiaBritish Columbia Cancer Agency, Vancouver, BC, Canada.
G JerusalemCHU Liege and Liège University, Liège, Belgium.
M De LaurentiisIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy.
S-A ImCancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
K PetrakovaMasaryk Memorial Cancer Institute, Brno, Czech Republic.
G V BianchiFondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy.
M MartínInstituto 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.
A NuschPractice for Hematology and Internal Oncology, Velbert, Germany.
G S SonkeNetherlands Cancer Institute/Borstkanker Onderzoek Groep Study Center, Amsterdam, The Netherlands.
L De la Cruz-MerinoHospital Universitario Virgen Macarena, Seville, Spain.
J T BeckHighlands Oncology, Springdale, AR, USA.
J P ZarateNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Y WangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
A ChakravarttyNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
C WangNovartis Pharma AG, Basel, Switzerland.
D J SlamonDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Novartis (United States) · USBC Cancer Agency · CACentro de Investigación Biomédica en Red de Cáncer · ESFondazione IRCCS Istituto Nazionale dei Tumori · ITFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHighlands Oncology Group · USHospital Universitario Virgen Macarena · ESIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITMasaryk Memorial Cancer Institute · CZNovartis (Switzerland) · CHSeoul National University Hospital · KRThe Netherlands Cancer Institute · NLUniversitair Ziekenhuis Leuven · BEUniversity of California, Los Angeles · USUniversity of Liège · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase III MONALEESA-3 trial included first- (1L) and second-line (2L) patients and demonstrated a significant overall survival (OS) benefit for ribociclib + fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) in the final protocol-specified and exploratory (longer follow-up) OS analyses. At the time of these analyses, the full OS benefit of 1L ribociclib was not completely characterized because the median OS (mOS) was not reached. As CDK4/6 inhibitor (CDK4/6i) + endocrine therapy (ET) is now a preferred option for 1L HR+/HER2- ABC, we report an exploratory analysis (median follow-up, 70.8 months; 14.5 months longer than the prior analysis) to fully elucidate the OS benefit in the MONALEESA-3 1L population.

methodsPostmenopausal patients with HR+/HER2- ABC were randomized 2:1 to 1L/2L fulvestrant + ribociclib or placebo. OS in 1L patients (de novo disease or relapse > 12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan-Meier methods. Progression-free survival 2 (PFS2) and chemotherapy-free survival (CFS) were analyzed. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615).

resultsAt data cutoff (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50-0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored ribociclib versus placebo. Among those who discontinued treatment, 16.7% and 35.0% on ribociclib or placebo, respectively, received a subsequent CDK4/6i. No new safety signals were observed.

conclusionsThis analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS benefit of ribociclib was maintained through extended follow-up, further supporting its use in HR+/HER2- ABC.

Indexed as

Breast NeoplasmsAminopyridinesFemaleFulvestrantHumansPostmenopauseProportional Hazards ModelsPurinesAminopyridinesFulvestrantPurinesribociclibAdvanced breast cancerCDK4/6 inhibitorFirst lineOverall survivalRibociclib

Identifiers

PMID37653397
PMCPMC10469877
OpenAlexW4386329445

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.