Evidence map›Paper›PMID 25231953›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.

M Piccart, G N Hortobagyi, M Campone, K I Pritchard, F Lebrun, Y Ito, S Noguchi, A Perez, H S Rugo, I Deleu and 10 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. 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 284 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
284citing papers in PubMed, 12 pooled it
47.3field-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.

NCT00863655 phase3completednot on this map

A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2014Enrolled724ConditionsBreast CancerArmsEverolimus, Exemestane, Everolimus Placebo
NCT07753954 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Imaging to Re-evaluate Elacestrant Clinical Application

TypeinterventionalSponsorJules Bordet InstituteRan2026 to 2031Enrolled160ConditionsER+ / HER2- Advanced Breast CancerArmsElacestrant
3 · Its place in the literature

Who cites it

284 citing papers in PubMed, 12 syntheses or guidelines pooled it, 563 citations in OpenAlex.

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  10. Review of concepts in therapeutic decision-making in HER2-negative luminal metastatic breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Pooled it
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  12. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)†.Annals of oncology : official journal of the European Society for Medical Oncology · 2018
    Guideline
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  19. Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2021
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224 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

20 authors at 15 institutions in 7 countries.

M PiccartDepartment of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: martine.piccart@bordet.be.
G N HortobagyiDepartment of Breast Medical Oncology, Multidisciplinary Breast Cancer Research Program, University of Texas MD Anderson Cancer Center, Houston, USA.
M CamponeInstitut de Cancérologie de l'Ouest, René Gauducheau, Centre de Recherche en Cancérologie, Nantes Saint Herblain, France.
K I PritchardDepartment of Medicine, Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, Canada.
F LebrunDepartment of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Y ItoDepartment of Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo.
S NoguchiDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
A PerezBreast Cancer Centers, Memorial Cancer Institute, Hollywood.
H S RugoBreast Oncology and Clinical Trials Education, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.
I DeleuOncologic Centre, AZ Nikolaas, Sint-Niklaas, Belgium.
H A BurrisSarah Cannon Research Institute, Nashville, USA.
L ProvencherCentre des Maladies du Sein Deschênes-Fabia, CHU-Hôpital du Saint Sacrement, Québec, Canada.
P NevenMultidisciplinary Breast Centre and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven, Belgium.
M GnantDepartment of Surgery, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.
M ShtivelbandIronwood Cancer & Research Centers, Chandler.
C WuNovartis Pharmaceuticals Corporation, East Hanover.
J FanNovartis Pharmaceuticals Corporation, East Hanover.
W FengNovartis Pharmaceuticals Corporation, East Hanover.
T TaranNovartis Pharmaceuticals Corporation, East Hanover.
J BaselgaMemorial Sloan-Kettering Cancer Center, New York, USA.
Novartis (Switzerland) · CHInstitut Jules Bordet · BEComprehensive Cancer Center Vienna · ATHôpital du Saint-Sacrement · CAInstitut de Cancérologie de l'Ouest · FRIronwood Pharmaceuticals (United States) · USJapanese Foundation For Cancer Research · JPKU Leuven · BEMemorial Sloan Kettering Cancer Center · USOsaka University · JPSarah Cannon · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · USUniversity of Toronto · CAVlaamse Vereniging voor Obstetrie en Gynaecolo · BE

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

backgroundThe BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here. PATIENTS AND

methodsBOLERO-2 is a phase III, double-blind, randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo (PBO) + EXE 25 mg/day in postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs. The primary end point was PFS by local investigator assessment; OS was a key secondary end point.

resultsAt the time of data cutoff (3 October 2013), 410 deaths had occurred and 13 patients remained on treatment. Median OS in patients receiving EVE + EXE was 31.0 months [95% confidence interval (CI) 28.0-34.6 months] compared with 26.6 months (95% CI 22.6-33.1 months) in patients receiving PBO + EXE (hazard ratio = 0.89; 95% CI 0.73-1.10; log-rank P = 0.14). Poststudy treatments were received by 84% of patients in the EVE + EXE arm versus 90% of patients in the PBO + EXE arm. Types of poststudy therapies were balanced across arms, except for chemotherapy (53% EVE + EXE versus 63% PBO + EXE). No new safety concerns were identified.

conclusionsIn BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001). Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting. TRIAL REGISTRATION NUMBER: NCT00863655.

Indexed as

AndrostadienesBreast NeoplasmsDouble-Blind MethodErbB ReceptorsEverolimusFemaleHumansPlacebosSirolimusSurvival AnalysisAndrostadienesErbB ReceptorsEverolimusexemestanePlacebosSirolimuseverolimusexemestanehormone-receptor-positive breast canceroverall survival

Identifiers

PMID25231953
PMCPMC6267855
OpenAlexW2151082560

What OpenQuestion holds

Textmetadata
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.