Evidence map›Paper›PMID 29058175›Full record

Trial reportBreast cancer research and treatment2018

Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trial.

Gabe S Sonke, Lowell L Hart, Mario Campone, Frans Erdkamp, Wolfgang Janni, Sunil Verma, Cristian Villanueva, Erik Jakobsen, Emilio Alba, Erik Wist and 9 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized 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 2 registered trials, which are not on this map. Cited by 51 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 10 pooled it
7.6field-weighted citation impact, top 2% 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
NCT03944434 phase2active not recruitingnot on this map

Phase II, Multicenter, Single Arm Trial to Assess the Feasibility of First Line Ribociclib in Combination with a Non Steroidal Aromatase Inhibitor in Elderly Patients with Hormone Receptor Positive/HER2 Negative Advanced Breast Cancer

TypeinterventionalSponsorFondazione Sandro PitiglianiRan2018 to 2025Enrolled116ConditionsBreast CancerArmsRibociclib, Aromatase Inhibitors, non steroideal, LHRH agonist
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 10 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Trial
  12. Trial
  13. Observational
  14. Review
  15. CDK4/6 inhibitors for metastatic breast cancer in routine clinical practice in Spain: survey of patterns of use and oncologists' perceptions.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
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

19 authors at 17 institutions in 10 countries.

Gabe S SonkeDepartment of Medical Oncology, Netherlands Cancer Institute/BOOG Study Center, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. g.sonke@nki.nl.
Lowell L HartFlorida Cancer Specialists, 8931 Colonial Center Dr Suite 300, Fort Myers, FL, 33905, USA.
Mario CamponeInstitut de Cancérologie de l'Ouest - René Gauducheau Centre de Recherche en Cancérologie, Boulevard Jacques Monod, Nantes, 44805, Saint-Herblain, France.
Frans ErdkampZuyderland Medical Center, Sittard-Geleen/Heerlen, 6162 BG, Geleen, The Netherlands.
Wolfgang JanniUniversitätsklinikum Ulm, Prittwitzstraße 43, 89075, Ulm, Germany.
Sunil VermaTom Baker Cancer Centre, 1331 29th Street NW, Calgary, AB, T2N 4N2, Canada.
Cristian VillanuevaUniversity Hospital of Besançon, Hospital Jean-Minjoz, 25000, Besançon, France.
Erik JakobsenLillebælt Hospital, Kabbeltoft 25, 7100, Vejle, Denmark.
Emilio AlbaHospital Universitario Virgen de la Victoria, IBIMA, 29010, Málaga, Spain.
Erik WistOslo University Hospital, Ullernchausseen 70 Radiumhospitalet, 0379, Oslo, Norway.
Anne M FavretVirginia Cancer Specialists PC, US Oncology, 8503 Arlington Blvd #400, Fairfax, VA, 22031, USA.
Thomas BachelotCentre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France.
Roberto HeggHospital Pérola Byington Centro de Referência da Saúde da Mulher, Av. Brigadeiro Luís Antônio, 683-Bela Vista, São Paulo, SP, 01317-000, Brazil.
Paul Wheatley-PriceOttawa Hospital Research Institute, University of Ottawa, 501, Smyth Road, Ottawa, ON, K1H 8L6, Canada.
Farida SouamiNovartis Pharma AG, CH-4002, Basel, Switzerland.
Santosh SutradharNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA.
Michelle MillerNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA.
Caroline GermaNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA.
Howard A BurrisSarah Cannon Research Institute, 250 25th Avenue North #100, Nashville, TN, 37203, USA.
Novartis (United States) · USCentre Hospitalier Universitaire de Besançon · FRCentre Léon Bérard · FRFlorida Cancer Specialists & Research Institute · USHospital Pérola Byington · BRInstitut de Cancérologie de l'Ouest · FRInstituto de Investigación Biomédica de Málaga · ESLillebaelt Hospital · DKNovartis (Switzerland) · CHOccupational Cancer Research Centre · CAOslo University Hospital · NOSarah Cannon · USThe Netherlands Cancer Institute · NLUniversity Hospital Ulm · DEUniversity of Ottawa · CAVirginia Cancer Specialists · USZuyderland Medisch Centrum · NL

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 elderly patients with HR+, HER2- advanced breast cancer.

methods668 postmenopausal 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); 295 patients were aged ≥ 65 years. Patients were randomized to ribociclib (600 mg/day; 3-weeks-on/1-week-off) plus letrozole (2.5 mg/day) or placebo plus letrozole until disease progression, unacceptable toxicity, death, or treatment discontinuation. The primary endpoint was PFS, which was evaluated in elderly (≥ 65 years) and younger (< 65 years) patients. Secondary endpoints included response rates and safety.

resultsRibociclib plus letrozole significantly improved PFS vs placebo plus letrozole in elderly (hazard ratio: 0.608; 95% CI 0.394-0.937) and younger patients (hazard ratio: 0.523; 95% CI 0.378-0.723). Overall response rates were numerically higher in the ribociclib vs placebo arm, regardless of age. Ribociclib plus letrozole was well tolerated in elderly patients, with the safety profile similar to the overall study population. Nausea, vomiting, alopecia, and diarrhea were > 10% more frequent in the ribociclib plus letrozole vs placebo plus letrozole arm in both subgroups; most events were grade 1/2. In elderly patients, grade 1/2 anemia and fatigue were > 10% more frequent in the ribociclib plus letrozole vs placebo plus letrozole arm and discontinuation rates were similar in both arms.

conclusionsAddition of ribociclib to letrozole is a valid therapeutic option for elderly patients with HR+, HER2- advanced breast cancer in the first-line setting.

Indexed as

AgedAged, 80 and overAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansLetrozoleMiddle AgedNitrilesPurinesReceptors, EstrogenReceptors, ProgesteroneAminopyridinesBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozoleNitrilesPurinesReceptors, EstrogenReceptors, ProgesteroneribociclibTriazolesBreast cancerCDK inhibitorElderlyEndocrine therapyHormone receptor-positiveRibociclib

Identifiers

PMID29058175
PMCPMC5807486
OpenAlexW2765692744

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.