Evidence map›Paper›PMID 34092112›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Randomized Phase III Postoperative Trial of Platinum-Based Chemotherapy Versus Capecitabine in Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131.

Ingrid A Mayer, Fengmin Zhao, Carlos L Arteaga, William F Symmans, Ben H Park, Brian L Burnette, Amye J Tevaarwerk, Sofia F Garcia, Karen L Smith, Della F Makower and 15 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 4 pooled it
9.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 4 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Platinum-based chemotherapy for early triple-negative breast cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
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  4. Pooled it
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  6. FOXC1 Expression Predicts Capecitabine Efficacy in Patients with Triple-Negative Breast Cancer from the GEICAM_CIBOMA Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  7. Trial
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  10. Triple-Negative PAM50 Non-Basal Breast Cancer Subtype Predicts Benefit from Extended Adjuvant Capecitabine.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  11. Trial
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  14. Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  15. Review
  16. Observational
  17. Article
  18. Article
  19. Article
  20. Article

24 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 1 country.

Ingrid A MayerVanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.ORCID 0000-0001-8147-335X
Fengmin ZhaoDana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA.
Carlos L ArteagaUT Southwestern Simmons Cancer Center, Dallas, TX.
William F SymmansMD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-1526-184X
Ben H ParkVanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.ORCID 0000-0001-8119-2291
Brian L BurnetteCancer Research of Wisconsin and Northern Michigan (CROWN) NCORP, Green Bay, WI.
Amye J TevaarwerkUniversity of Wisconsin Carbone Cancer Center, Madison, WI.ORCID 0000-0002-8087-5119
Sofia F GarciaNorthwestern University, Evanston, IL.ORCID 0000-0003-3300-385X
Karen L SmithJohns Hopkins University, Sidney Kimmel Cancer Center, Baltimore, MD.ORCID 0000-0002-6687-0119
Della F MakowerMontefiore Medical Center, Bronx, NY.ORCID 0000-0002-8125-2474
Margaret BlockAlegent Health Bergan Mercy Medical Center, Omaha, NE.
Kimberly A MorleySaint Joseph Mercy Hospital, Ann Arbor, MI.
Chirag R JaniPhoebe Putney Memorial Hospital, Albany, GA.
Craig MescherMetro-Minnesota Community Oncology Research Consortium, St Louis Park, MN.
Shabana J DewaniColumbus Oncology and Hematology Associates Inc, Columbus, OH.
Bernard TawfikUniversity of New Mexico Cancer Center, Albuquerque, NM.ORCID 0000-0002-4380-2471
Lisa E FlaumNorthwestern University, Evanston, IL.
Erica L MayerDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-5430-8957
William M SikovWomen and Infants Hospital of Rhode Island, Providence, RI.ORCID 0000-0001-5451-6449
Eve T RodlerUniversity of California, Davis, Davis, CA.ORCID 0000-0003-2064-683X
Lynne I WagnerWake Forest University Health Sciences, Winston-Salem, NC.ORCID 0000-0001-9685-4796
Angela M DeMicheleUniversity of Pennsylvania/Abramson Cancer Center, Philadelphia, PA.ORCID 0000-0003-1297-4251
Joseph A SparanoMontefiore Medical Center, Bronx, NY.ORCID 0000-0002-9031-2010
Antonio C WolffJohns Hopkins University, Sidney Kimmel Cancer Center, Baltimore, MD.ORCID 0000-0003-3734-1063
Kathy D MillerIndiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN.
Johns Hopkins University · USMontefiore Medical Center · USNorthwestern University · USVanderbilt University Medical Center · USColumbus Oncology and Hematology Associates · USDana-Farber Cancer Institute · USECOG-ACRIN Cancer Research Group · USIndiana University Health · USMercy Medical Center · USMercy Medical Center · USMetro-Minnesota Community Oncology Research Consortium · USMichigan Cancer Research Consortium · USPhoebe Putney Memorial Hospital · USProvidence College · USSouthwestern Medical Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, Davis · USUniversity of New Mexico · USUniversity of Pennsylvania · USUniversity of Wisconsin Carbone Cancer Center · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Tumor Immunology and Microenvironment Research ProgramP30CA068485 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI STACIE B DUSETZINA · 1995 to 2026
$172.8M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
UT Southwestern Medical Center Simmons Comprehensive Cancer CenterP30CA142543 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI MELANIE H. COBB · 2010 to 2026
$53.7M
TISSUE CoreP50CA098131 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PARK, BEN HO, PIETENPOL, JENNIFER A · 2003 to 2024
$48.7M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
NCI NIH HHS P30 CA068485NCI NIH HHS P30 CA142543NCI NIH HHS P50 CA098131NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189809NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189851NCI NIH HHS UG1 CA189856NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233270NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233302NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233329NCI NIH HHS UG1 CA233340NCI NIH HHS UG1 CA239769
6 · The paper itself

Abstract

purposePatients with triple-negative breast cancer (TNBC) and residual invasive disease (RD) after completion of neoadjuvant chemotherapy (NAC) have a high-risk for recurrence, which is reduced by adjuvant capecitabine. Preclinical models support the use of platinum agents in the TNBC basal subtype. The EA1131 trial hypothesized that invasive disease-free survival (iDFS) would not be inferior but improved in patients with basal subtype TNBC treated with adjuvant platinum compared with capecitabine. PATIENTS AND

methodsPatients with clinical stage II or III TNBC with ≥ 1 cm RD in the breast post-NAC were randomly assigned to receive platinum (carboplatin or cisplatin) once every 3 weeks for four cycles or capecitabine 14 out of 21 days every 3 weeks for six cycles. TNBC subtype (basal

resultsFour hundred ten of planned 775 participants were randomly assigned to platinum or capecitabine between 2015 and 2021. After median follow-up of 20 months and 120 iDFS events (61% of full information) in the 308 (78%) patients with basal subtype TNBC, the 3-year iDFS for platinum was 42% (95% CI, 30 to 53) versus 49% (95% CI, 39 to 59) for capecitabine. Grade 3 and 4 toxicities were more common with platinum agents. The Data and Safety Monitoring Committee recommended stopping the trial as it was unlikely that further follow-up would show noninferiority or superiority of platinum.

conclusionPlatinum agents do not improve outcomes in patients with basal subtype TNBC RD post-NAC and are associated with more severe toxicity when compared with capecitabine. Participants had a lower than expected 3-year iDFS regardless of study treatment, highlighting the need for better therapies in this high-risk population.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineFemaleHumansMiddle AgedNeoadjuvant TherapyPlatinumTriple Negative Breast NeoplasmsCapecitabinePlatinum

Identifiers

PMID34092112
PMCPMC8577688
OpenAlexW3172346887

What OpenQuestion holds

Textmetadata
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Registered trials

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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.