Evidence map›Paper›PMID 25605862›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane.

Peter A Kaufman, Ahmad Awada, Chris Twelves, Louise Yelle, Edith A Perez, Galina Velikova, Martin S Olivo, Yi He, Corina E Dutcus, Javier Cortes

5 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 216 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
216citing papers in PubMed, 7 pooled it
23.9field-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.

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
NCT03264547 phase3completednot on this mapstarted 2017, after this paper: background citation

A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)

TypeinterventionalSponsorJapan Breast Cancer Research GroupRan2017 to 2024Enrolled446ConditionsBreast CancerArmsPertuzumab, Trastuzumab, Docetaxel, Paclitaxel, Eribulin
NCT03637868 phase2withdrawnnot on this mapstarted 2019, after this paper: background citation

A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes

TypeinterventionalSponsorInstitut Paoli-CalmettesRan2019 to 2020Enrolled0ConditionsMetastatic Breast CancerArmsEribulin
NCT05965141 phase1 / phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer

TypeinterventionalSponsorSecond Affiliated Hospital of Guangzhou Medical UniversityRan2023 to 2025Enrolled38ConditionsOvarian CancerArmsAribulin, carboplatin, bevacizumab
NCT06539559 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy, Adverse Events and Resistant Mechanism of Eribulin Combined With or Without Bevacizumab for Advanced HER2 Negative Breast Cancer Patients, an Open-label, Randomized, Multi-center PhaseⅡ Clinical Trial.

TypeinterventionalSponsorWang JiayuRan2024 to 2026Enrolled60ConditionsBreast Neoplasms, Neoplasm Metastasis, Drug Therapy, BevacizumabArmsEribulin, Bevacizumab
3 · Its place in the literature

Who cites it

216 citing papers in PubMed, 7 syntheses or guidelines pooled it, 457 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3).Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Guideline
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Pegylated liposomal doxorubicin (DuomeisuBreast cancer research and treatment · 2023
    Trial
  19. Trial
  20. Trial

156 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

10 authors at 1 institution in 1 country.

Peter A KaufmanPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain. Peter.A.Kaufman@hitchcock.org.
Ahmad AwadaPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Chris TwelvesPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Louise YellePeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Edith A PerezPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Galina VelikovaPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Martin S OlivoPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Yi HePeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Corina E DutcusPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Javier CortesPeter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain.
Institut Jules Bordet · BE

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
Medical Research Council MR/L01629X/1NCI NIH HHS P30 CA015083NCI NIH HHS P30 CA023108
6 · The paper itself

Abstract

purposeThis phase III randomized trial (ClinicalTrials.gov identifier: NCT00337103) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer (MBC). PATIENTS AND

methodsWomen with MBC who had received prior anthracycline- and taxane-based therapy were randomly assigned to receive eribulin or capecitabine as their first-, second-, or third-line chemotherapy for advanced/metastatic disease. Stratification factors were human epidermal growth factor receptor-2 (HER2) status and geographic region. Coprimary end points were overall survival (OS) and progression-free survival (PFS).

resultsMedian OS times for eribulin (n = 554) and capecitabine (n = 548) were 15.9 and 14.5 months, respectively (hazard ratio [HR], 0.88; 95% CI, 0.77 to 1.00; P = .056). Median PFS times for eribulin and capecitabine were 4.1 and 4.2 months, respectively (HR, 1.08; 95% CI, 0.93 to 1.25; P = .30). Objective response rates were 11.0% for eribulin and 11.5% for capecitabine. Global health status and overall quality-of-life scores over time were similar in the treatment arms. Both treatments had manageable safety profiles consistent with their known adverse effects; most adverse events were grade 1 or 2.

conclusionIn this phase III study, eribulin was not shown to be superior to capecitabine with regard to OS or PFS.

Indexed as

AdultAgedAged, 80 and overAnthracyclinesAntimetabolites, AntineoplasticBreast NeoplasmsCapecitabineDeoxycytidineFemaleFluorouracilFuransHumansKetonesMiddle AgedPolyether PolyketidesTaxoidsAnthracyclinesAntimetabolites, AntineoplasticCapecitabineDeoxycytidineeribulinFluorouracilFuransKetonesPolyether PolyketidesTaxoids

Identifiers

PMID25605862
PMCPMC4463422
OpenAlexW2137545466

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.