Evidence map›Paper›PMID 31796073›Full record

ArticleBreast cancer research : BCR2019

NSABP FB-7: a phase II randomized neoadjuvant trial with paclitaxel + trastuzumab and/or neratinib followed by chemotherapy and postoperative trastuzumab in HER2

Samuel A Jacobs, André Robidoux, Jame Abraham, José Manuel Pérez-Garcia, Nicla La Verde, James M Orcutt, Marina E Cazzaniga, Fanny Piette, Silvia Antolín, Elena Aguirre and 16 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Breast cancer research : BCR, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01008150 (A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens With Weekly Paclitaxel Plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide With Postoperative Trastuzumab in Women With Locally Advanced HER2-Positive Breast Cancer), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 10% 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.

NCT01008150 phase2completednot on this map

A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens With Weekly Paclitaxel Plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide With Postoperative Trastuzumab in Women With Locally Advanced HER2-Positive Breast Cancer

TypeinterventionalSponsorNSABP Foundation IncRan2010 to 2016Enrolled141ConditionsBreast CancerArmsPaclitaxel, Trastuzumab, Neratinib, Doxorubicin, Cyclophosphamide
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 11 institutions in 6 countries.

Samuel A JacobsNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA. samuel.jacobs@nsabp.org.
André RobidouxNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Jame AbrahamNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
José Manuel Pérez-GarciaQuironSalud Group, IOB Institute of Oncology, Madrid, Barcelona, Spain.
Nicla La VerdePresent address: ASST Fatebenefratelli Sacco - PO Luigi Sacco, Milan, Italy.
James M OrcuttNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Marina E CazzanigaMedica Scientia Innovation Research (MedSIR), Barcelona, Spain.
Fanny PietteInternational Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.
Silvia AntolínHospital Universitario, Coruña, Spain.
Elena AguirreMedica Scientia Innovation Research (MedSIR), Barcelona, Spain.
Javier CortesQuironSalud Group, IOB Institute of Oncology, Madrid, Barcelona, Spain.
Antonio Llombart-CussacMedica Scientia Innovation Research (MedSIR), Barcelona, Spain.
Serena Di CosimoMedica Scientia Innovation Research (MedSIR), Barcelona, Spain.
Rim S KimNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Huichen FengNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Corey LipchikNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Peter C LucasNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Ashok SrinivasanNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Ying WangNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Nan SongNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Patrick G GavinNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
April D BalousekNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Soonmyung PaikNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Carmen J AllegraDepartment of Medicine, University of Florida Health, Gainsville, FL, USA.
Norman WolmarkNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
Katherine L Pogue-GeileNSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.
NSABP Foundation · USMedSIR (Spain) · ESASST Fatebenefratelli Sacco · ITCentre Hospitalier de l’Université de Montréal · CAComplexo Hospitalario Universitario A Coruña · ESFondazione IRCCS Istituto Nazionale dei Tumori · ITHospital Quirónsalud Barcelona · ESInternational Drug Development Institute (Belgium) · BEUniversity of Florida Health · USUniversity of Pittsburgh · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe primary aim of NSABP FB-7 was to determine the pathologic complete response (pCR) rate in locally advanced HER2-positive (HER2 EXPERIMENTAL

designpCR was tested for association with treatment, gene expression, and a single nucleotide polymorphism (SNP) in the Fc fragment of the IgG receptor IIIa-158V/F (FCGR3A). Pre-treatment biopsies and residual tumors were also compared to identify molecular changes.

resultsThe numerical pCR rate in the trastuzumab plus neratinib arm (50% [95%CI 34-66%]) was greater than that for single-targeted therapies with trastuzumab (38% [95%CI 24-54]) or neratinib (33% [95%CI 20-50]) in the overall cohort but was not statistically significant. Hormone receptor-negative (HR

conclusionsCombining trastuzumab plus neratinib with paclitaxel increased the absolute pCR rate in the overall cohort and in HR TRIALS REGISTRATION: ClinicalTrials.gov, NCT01008150. Retrospectively registered on October 5, 2010.

Indexed as

Breast cancerNeoadjuvantNeratinib

Identifiers

PMID31796073
PMCPMC6892191
OpenAlexW4243460686

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.