Evidence map›Paper›PMID 29164421›Full record

Trial reportBreast cancer research and treatment2018

Ribociclib plus letrozole versus letrozole alone in patients with de novo HR+, HER2- advanced breast cancer in the randomized MONALEESA-2 trial.

Joyce O'Shaughnessy, Katarina Petrakova, Gabe S Sonke, Pierfranco Conte, Carlos L Arteaga, David A Cameron, Lowell L Hart, Cristian Villanueva, Erik Jakobsen, Joseph T Beck and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01958021 (A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease), which is not on this map. Cited by 68 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 8 pooled it
10.0field-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.

NCT01958021 phase3completednot on this map

A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2023Enrolled668ConditionsAdvanced, Metastatic Breast CancerArmsRibociclib, Letrozole, Placebo
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 8 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. Guideline
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8 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

15 authors at 14 institutions in 8 countries.

Joyce O'ShaughnessyTexas Oncology-Baylor Charles A. Sammons Cancer Center and US Oncology Network, 3410 Worth Street, Suite 400, Dallas, TX, 75246, USA. Joyce.OShaughnessy@USOncology.com.ORCID http://orcid.org/0000-0001-6764-2807
Katarina PetrakovaMasaryk Memorial Cancer Institute, Žlutý kopec 543/7, 656 53, Brno, Czech Republic.
Gabe S SonkeNetherlands Cancer Institute and BOOG Study Center, IJsbaanpad 9, 1076 CV, Amsterdam, The Netherlands.
Pierfranco ConteUniversity of Padova and Istituto Oncologico Veneto, IRCCS, Via Gattamelata, 64, Padua, Italy.
Carlos L ArteagaVanderbilt-Ingram Cancer Center, 1301 Medical Center Dr #1710, Nashville, TN, 37232, USA.
David A CameronEdinburgh Cancer Centre, University of Edinburgh, Crewe Rd S, Edinburgh, EH4 2XR, UK.
Lowell L HartSarah Cannon Research Institute, Fort Myers, FL, 33916, USA.
Cristian VillanuevaUniversity Hospital of Besançon, Jean-Minjoz University Hospital, 3 Boulevard Alexandre Fleming, 25000, Besançon, France.
Erik JakobsenLillebaelt Hospital, Kabbeltoft 25, 7100, Vejle, Denmark.
Joseph T BeckHighlands Oncology Group, 3232 N Northhills Blvd, Fayetteville, AR, 72703, USA.
Deborah LindquistArizona Oncology, US Oncology Network, 3700 W State Rte 89A, Sedona, AZ, 86336, USA.
Farida SouamiNovartis Pharma AG, Fabrikstrasse 2, 4056, Basel, Switzerland.
Shoubhik MondalNovartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
Caroline GermaNovartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
Gabriel N HortobagyiUniversity of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.
Tris Pharma (United States) · USCentre Hospitalier Universitaire de Besançon · FREdinburgh Cancer Research · GBHighlands Oncology Group · USIstituto Oncologico Veneto · ITLillebaelt Hospital · DKMasaryk Memorial Cancer Institute · CZNovartis (Switzerland) · CHSarah Cannon · USTexas Oncology · USThe Netherlands Cancer Institute · NLThe University of Texas MD Anderson Cancer Center · USThe US Oncology Network · USVanderbilt-Ingram Cancer Center

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDetermine the efficacy and safety of first-line ribociclib plus letrozole in patients with de novo advanced breast cancer.

methodsPostmenopausal women with HR+ , HER2- advanced breast cancer and no prior systemic therapy for advanced disease were enrolled in the Phase III MONALEESA-2 trial (NCT01958021). Patients were randomized to ribociclib (600 mg/day; 3 weeks-on/1 week-off) plus letrozole (2.5 mg/day; continuous) or placebo plus letrozole until disease progression, unacceptable toxicity, death, or treatment discontinuation. The primary endpoint was investigator-assessed progression-free survival; predefined subgroup analysis evaluated progression-free survival in patients with de novo advanced breast cancer. Secondary endpoints included safety and overall response rate.

resultsSix hundred and sixty-eight patients were enrolled, of whom 227 patients (34%; ribociclib plus letrozole vs placebo plus letrozole arm: n = 114 vs. n = 113) presented with de novo advanced breast cancer. Median progression-free survival was not reached in the ribociclib plus letrozole arm versus 16.4 months in the placebo plus letrozole arm in patients with de novo advanced breast cancer (hazard ratio 0.45, 95% confidence interval 0.27-0.75). The most common Grade 3/4 adverse events were neutropenia and leukopenia; incidence rates were similar to those observed in the full MONALEESA-2 population. Ribociclib dose interruptions and reductions in patients with de novo disease occurred at similar frequencies to the overall study population.

conclusionsRibociclib plus letrozole improved progression-free survival vs placebo plus letrozole and was well tolerated in postmenopausal women with HR+, HER2- de novo advanced breast cancer.

Indexed as

AdultAgedAged, 80 and overAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreastBreast NeoplasmsChemotherapy-Induced Febrile NeutropeniaFemaleHumansIncidenceKaplan-Meier EstimateLetrozoleLeukopeniaMiddle AgedPostmenopauseAminopyridinesLetrozolePurinesReceptors, EstrogenReceptors, ProgesteroneribociclibBreast cancerCDK inhibitorDe novo advanced breast cancerEndocrine therapyHormone receptor-positiveRibociclib

Identifiers

PMID29164421
PMCPMC5847028
OpenAlexW2769552107

What OpenQuestion holds

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LicenceCC BY
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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.