Evidence map›Paper›PMID 27398025›Full record

ArticleBreast cancer : basic and clinical research2016

Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer.

Chris Twelves, Ahmad Awada, Javier Cortes, Louise Yelle, Galina Velikova, Martin S Olivo, James Song, Corina E Dutcus, Peter A Kaufman

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Breast cancer : basic and clinical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00337103 (A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 7% 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.

NCT00337103 phase3completednot on this map

A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

TypeinterventionalSponsorEisai Inc.Ran2006 to 2017Enrolled1,276ConditionsMetastatic Breast CancerArmsEribulin Mesylate, Capecitabine
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
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  3. Sacituzumab govitecan in HRNature medicine · 2024
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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

9 authors at 4 institutions in 4 countries.

Chris TwelvesSection of Clinical Cancer Research, Leeds Institute of Cancer and Pathology and St James's Institute of Oncology, Leeds, UK.
Ahmad AwadaMedical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium.
Javier CortesVall D'Hebron University Institute of Oncology, Barcelona, Spain.; Oncology Department, Ramon y Cajal University Hospital, Madrid, Spain.
Louise YelleDepartment of Medicine, University of Montreal, Montreal, QC, Canada.
Galina VelikovaDepartment of Oncology, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, University of Leeds, Leeds, UK.
Martin S OlivoOncology PCU, Department of Clinical Development, Eisai Inc., Woodcliff Lake, NJ, USA.
James SongFormerly of Department of Medical Affairs, Eisai Inc., Woodcliff Lake, NJ, USA.
Corina E DutcusDepartment of Clinical Development, Oncology, Eisai Inc., Woodcliff Lake, NJ, USA.
Peter A KaufmanSection of Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Dartmouth–Hitchcock Medical Center · USInstitut Jules Bordet · BEInstituto Cajal · ESUniversité de Montréal · CA

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108
6 · The paper itself

Abstract

PURPOSE AND

methodsOur secondary analyses compared survival with eribulin versus capecitabine in various patient subgroups from a phase 3, open-label, randomized study. Eligible women aged ≥18 years with advanced/metastatic breast cancer and ≤3 prior chemotherapies (≤2 for advanced/metastatic disease), including an anthracycline and taxane, were randomized 1:1 to intravenous eribulin mesylate 1.4 mg/m(2) on days 1 and 8 or twice-daily oral capecitabine 1250 mg/m(2) on days 1-14 (21-day cycles).

resultsIn the intent-to-treat population (eribulin 554 and capecitabine 548), overall survival appeared longer with eribulin than capecitabine in various subgroups, including patients with human epidermal growth factor receptor 2-negative (15.9 versus 13.5 months, respectively), estrogen receptor-negative (14.4 versus 10.5 months, respectively), and triple-negative (14.4 versus 9.4 months, respectively) disease. Progression-free survival was similar between the treatment arms.

conclusionsPatients with advanced/metastatic breast cancer and human epidermal growth factor receptor 2-, estrogen receptor-, or triple-negative disease may gain particular benefit from eribulin as first-, second-, and third-line chemotherapies. TRIAL REGISTRATION PRIMARY STUDY: This study reports the subgroup analyses of eribulin versus capecitabine from a phase 3, open-label, randomized study (www.clinicaltrials.gov; ClinicalTrials.gov identifier: NCT00337103).

Indexed as

advanced/metastatic breast cancercapecitabineeribulinhuman epidermal growth factor receptor 2subgroup analysessurvival

Identifiers

PMID27398025
PMCPMC4927108
OpenAlexW2460310329

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.