Evidence map›Paper›PMID 31821109›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2.

Louis Fehrenbacher, Reena S Cecchini, Charles E Geyer, Priya Rastogi, Joseph P Costantino, James N Atkins, John P Crown, Jonathan Polikoff, Jean-Francois Boileau, Louise Provencher and 10 more

Open access · greenAbstract 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 238 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
238citing papers in PubMed, 7 pooled it
13.8field-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

238 citing papers in PubMed, 7 syntheses or guidelines pooled it, 410 citations in OpenAlex.

  1. Pooled it
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  9. Computationally Derived Spatial Immune Signature Identifies Trastuzumab Responders in HER2+ Breast Cancer: NSABP B-41 Clinical Trial Validation.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  15. Utilization of MRI-based radiomics nomogram for predicting HER2-zero, -low, and -overexpression breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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178 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 9 institutions in 4 countries.

Louis FehrenbacherNRG Oncology, Pittsburgh, PA.
Reena S CecchiniNRG Oncology, Pittsburgh, PA.
Charles E GeyerNRG Oncology, Pittsburgh, PA.
Priya RastogiNRG Oncology, Pittsburgh, PA.
Joseph P CostantinoNRG Oncology, Pittsburgh, PA.
James N AtkinsNRG Oncology, Pittsburgh, PA.
John P CrownNRG Oncology, Pittsburgh, PA.
Jonathan PolikoffNRG Oncology, Pittsburgh, PA.
Jean-Francois BoileauNRG Oncology, Pittsburgh, PA.
Louise ProvencherNRG Oncology, Pittsburgh, PA.
Christopher StokoeNRG Oncology, Pittsburgh, PA.
Timothy D MooreNRG Oncology, Pittsburgh, PA.
André RobidouxNRG Oncology, Pittsburgh, PA.
Patrick J FlynnNRG Oncology, Pittsburgh, PA.
Virginia F BorgesNRG Oncology, Pittsburgh, PA.
Kathy S AlbainNRG Oncology, Pittsburgh, PA.
Sandra M SwainNRG Oncology, Pittsburgh, PA.
Soonmyung PaikNRG Oncology, Pittsburgh, PA.
Eleftherios P MamounasNRG Oncology, Pittsburgh, PA.
Norman WolmarkNRG Oncology, Pittsburgh, PA.
NRG Oncology · USGeorgetown University Medical Center · USHouston Methodist · USMark H. Zangmeister Cancer Center · USSoutheast Clinical Oncology Research Consortium · USUniversité Laval · CAUniversity of Colorado Denver · USUniversity of Florida Health · USUPMC Hillman 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
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Kaiser Permanente NCI National Community Oncology Research Program, NCORPUG1CA189821 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI Jennifer Marie Suga · 2014 to 2026
$44.4M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
PRIMARY BREAST CANCER THERAPY GROUP--NSABPU10CA044066 · NCI · UNIVERSITY OF MONTREAL HOSPITAL · PI ROBIDOUX, ANDRE · 1987 to 2012
$176k
NCI NIH HHS U10 CA044066NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189821NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233324
6 · The paper itself

Abstract

purposeAdjuvant trastuzumab reduces invasive breast cancer (IBC) recurrence and risk for death in patients with HER2-amplified or overexpressing IBC. A subset of patients in the landmark trastuzumab adjuvant trials who originally tested HER2-positive but were HER2-negative by central HER2 testing appeared to possibly benefit from trastuzumab. The objective for the NSABP B-47 trial was to determine whether the addition of trastuzumab to adjuvant chemotherapy (CRx) would improve invasive disease-free survival (IDFS) in patients with HER2-negative breast cancer. PATIENTS AND

methodsA total of 3,270 women with high-risk primary IBC were randomly assigned to CRx with or without 1 year of trastuzumab. Eligibility criteria included immunohistochemistry (IHC) score 1+ or 2+ with fluorescence in situ hybridization ratio (FISH) < 2.0 or, if ratio was not performed, HER2 gene copy number < 4.0. CRx was either docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide followed by weekly paclitaxel for 12 weeks.

resultsAt a median follow-up of 46 months, the addition of trastuzumab to CRx did not improve IDFS (5-year IDFS: 89.8% with CRx plus trastuzumab [CRxT]

conclusionThe addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC. Trastuzumab does not benefit women without IHC 3+ or FISH ratio-amplified breast cancer.

Indexed as

Antineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDocetaxelDoxorubicinErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunohistochemistryIn Situ Hybridization, FluorescenceMiddle AgedNeoplasm InvasivenessRisk FactorsAntineoplastic Agents, ImmunologicalCyclophosphamideDocetaxelDoxorubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumab

Identifiers

PMID31821109
PMCPMC7007289
OpenAlexW2994917610

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.