Evidence map›Paper›PMID 34380637›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast Cancer.

Cristina Saura, Judit Matito, Mafalda Oliveira, Hans Wildiers, Adam M Brufksy, Simon H Waters, Sara A Hurvitz, Beverly Moy, Sung-Bae Kim, William J Gradishar and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01808573 (A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.7field-weighted citation impact, top 13% 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.

NCT01808573 phase3completednot on this map

A study of neratinib plus capecitabine versus lapatinib plus capecitabine in patients with her2+ metastatic breast cancer who have received two or more prior her2-directed regimens in the metastatic setting (nala)

TypeinterventionalSponsorPuma Biotechnology, Inc.Ran2013 to 2019Enrolled621ConditionsHER2+ Metastatic Breast Cancer (MBC)Armsneratinib, capecitabine, lapatinib
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 20 citations in OpenAlex.

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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

20 authors at 12 institutions in 7 countries.

Cristina SauraVall d'Hebron University Hospital, Barcelona, Spain. csaura@vhio.net.ORCID 0000-0001-8296-5065
Judit MatitoVall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital Campus, Barcelona, Spain.
Mafalda OliveiraVall d'Hebron University Hospital, Barcelona, Spain.ORCID 0000-0001-9152-8799
Hans WildiersUniversity Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-8990-7837
Adam M BrufksyMagee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania.
Simon H WatersVelindre Cancer Centre, Cardiff, Wales, United Kingdom.ORCID 0000-0003-0205-4398
Sara A HurvitzUniversity of California at Los Angeles, Los Angeles, California.
Beverly MoyMassachusetts General Hospital Cancer Center, Boston, Massachusetts.
Sung-Bae KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea (South).
William J GradisharRobert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.
Geraldo Silva QueirozHospital Araújo Jorge, Goiânia, Goiás, Brazil.
Eduardo CronembergerCentro Regional Integrado de Oncologia, Fortaleza, Ceará, Brazil.ORCID 0000-0001-8493-7287
Gerald J WallweberMonogram Biosciences, Inc., Laboratory Corporation of America Holdings, South San Francisco, California.
Judith BebchukPuma Biotechnology Inc., Los Angeles, California.
Kiana KeyvanjahPuma Biotechnology Inc., Los Angeles, California.
Alshad S LalaniPuma Biotechnology Inc., Los Angeles, California.
Richard BrycePuma Biotechnology Inc., Los Angeles, California.ORCID 0000-0002-1507-9650
Ana VivancosVall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital Campus, Barcelona, Spain.
Lisa D EliPuma Biotechnology Inc., Los Angeles, California.
Suzette DelalogeGustave Roussy, Villejuif, France.
Puma Biotechnology (United States) · USHebron University · PSFundação Cearense de Meteorologia e Recursos Hídricos · BRHospital Araújo Jorge · BRInstitut Gustave Roussy · FRMagee-Womens Hospital · USMassachusetts General Hospital · USRobert H. Lurie Comprehensive Cancer Center of Northwestern UniversityTechnology Holding (United States) · USUniversity of California, Los Angeles · USUniversity of Ulsan · KRVelindre Cancer Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNeratinib plus capecitabine (N+C) demonstrated significant progression-free survival (PFS) benefit in NALA (NCT01808573), a randomized phase III trial comparing N+C with lapatinib + capecitabine (L+C) in 621 patients with HER2-positive (HER2 PATIENTS AND

methodsSomatic mutations were evaluated by next-generation sequencing on primary or metastatic samples. HER2 protein expression was evaluated by central IHC, H-score, and VeraTag/HERmark. p95 expression (truncated HER2) was measured by VeraTag. HRs were estimated using unstratified Cox proportional hazards models.

resultsFour hundred and twenty samples had successful sequencing: 34.0% had

conclusions

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCapecitabineCorrelation of DataFemaleHumansLapatinibNeoplasm MetastasisQuinolinesRetreatmentBiomarkers, TumorCapecitabineLapatinibneratinibQuinolines

Identifiers

PMID34380637
PMCPMC9401509
OpenAlexW3187091514

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.