Evidence map›Paper›PMID 29349598›Full record

ArticleInvestigational new drugs2018

Phase Ib study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer.

Andreas Schneeweiss, Tjoung-Won Park-Simon, Joan Albanell, Ulrik Lassen, Javier Cortés, Veronique Dieras, Marcus May, Christoph Schindler, Frederik Marmé, Juan Miguel Cejalvo and 17 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01918254 (Phase IB, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered in Combination With Pertuzumab and Paclitaxel in Patients With Metastatic Breast Cancer Expressing HER3 & HER2 Protein), which is not on this map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
2.5field-weighted citation impact, top 8% 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.

NCT01918254 phase1completednot on this map

Phase IB, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered in Combination With Pertuzumab and Paclitaxel in Patients With Metastatic Breast Cancer Expressing HER3 & HER2 Protein

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2016Enrolled66ConditionsBreast CancerArmsPaclitaxel, Pertuzumab, Lumretuzumab
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 77 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

27 authors at 14 institutions in 6 countries.

Andreas SchneeweissNational Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.
Tjoung-Won Park-SimonDepartment of Obstetrics and Gynecology, Division of Gynecological Oncology and Clinical Research Center, Hannover Medical School, Hannover, Germany.
Joan AlbanellDepartment of Medical Oncology, Hospital del Mar, CIBERONC, Barcelona, Spain.
Ulrik LassenRigshospitalet, Copenhagen, Denmark.
Javier CortésRamon y Cajal University Hospital, Madrid, Spain.
Veronique DierasDepartment of Medical Oncology, Institute Curie, Paris, France.
Marcus MayDepartment of Obstetrics and Gynecology, Division of Gynecological Oncology and Clinical Research Center, Hannover Medical School, Hannover, Germany.
Christoph SchindlerDepartment of Obstetrics and Gynecology, Division of Gynecological Oncology and Clinical Research Center, Hannover Medical School, Hannover, Germany.
Frederik MarméNational Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.
Juan Miguel CejalvoDepartment of Medical Oncology, Biomedical Health Research Institute INCLIVA, University of Valencia, Valencia and CIBERONC, Institute of Health Carlos III, Madrid, Spain.
Maria Martinez-GarciaDepartment of Medical Oncology, Hospital del Mar, CIBERONC, Barcelona, Spain.
Iria GonzalezDepartment of Medical Oncology, Hospital del Mar, CIBERONC, Barcelona, Spain.
Jose Lopez-MartinDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Anja WeltDepartment of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany.
Christelle LevyDepartments of Clinical Research Unit and Medical Oncology, Centre François Baclesse, Caen, France.
Florence JolyDepartments of Clinical Research Unit and Medical Oncology, Centre François Baclesse, Caen, France.
Francesca MichielinPharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, Switzerland.
Wolfgang JacobPharma Research and Early Development (pRED), Roche Innovation Center Munich, Penzberg, Germany. wolfgang.jacob@roche.com.ORCID http://orcid.org/0000-0002-8171-7542
Céline AdessiPharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, Switzerland.
Annie MoisanPharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, Switzerland.
Georgina Meneses-LorentePharma Research and Early Development (pRED), Roche Innovation Center Welwyn, Welwyn Garden City, UK.
Tomas RacekPharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, Switzerland.
Ian JamesA4P Consulting Ltd, Sandwich, UK.
Maurizio CeppiPharma Research and Early Development (pRED), Roche Innovation Center Munich, Penzberg, Germany.
Max HasmannPharma Research and Early Development (pRED), Roche Innovation Center Munich, Penzberg, Germany.
Martin WeisserPharma Research and Early Development (pRED), Roche Innovation Center Munich, Penzberg, Germany.
Andrés CervantesDepartment of Medical Oncology, Biomedical Health Research Institute INCLIVA, University of Valencia, Valencia and CIBERONC, Institute of Health Carlos III, Madrid, Spain.
Roche (Switzerland) · CHHospital Del Mar · ESMedizinische Hochschule Hannover · DERoche Pharma AG (Germany) · DECentre François Baclesse · FRHeidelberg University · DEUniversitat de València · ESEssen University Hospital · DEHospital Universitario 12 De Octubre · ESInstitut Curie · FRInstituto Cajal · ESPfizer (United Kingdom) · GBRigshospitalet · DKRoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose To investigate the safety and clinical activity of comprehensive human epidermal growth factor receptor (HER) family receptor inhibition using lumretuzumab (anti-HER3) and pertuzumab (anti-HER2) in combination with paclitaxel in patients with metastatic breast cancer (MBC). Methods This phase Ib study enrolled 35 MBC patients (first line or higher) with HER3-positive and HER2-low (immunohistochemistry 1+ to 2+ and in-situ hybridization negative) tumors. Patients received lumretuzumab (1000 mg in Cohort 1; 500 mg in Cohorts 2 and 3) plus pertuzumab (840 mg loading dose [LD] followed by 420 mg in Cohorts 1 and 2; 420 mg without LD in Cohort 3) every 3 weeks, plus paclitaxel (80 mg/m

trial registrationon ClinicalTrials.gov with the identifier NCT01918254 first registered on 3rd July 2013.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDiarrheaErb-b2 Receptor Tyrosine KinasesFemaleHumansHypokalemiaMiddle AgedPaclitaxelPolymorphism, Single NucleotideReceptor, ErbB-3Antibodies, Monoclonal, HumanizedAntineoplastic AgentsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesERBB3 protein, humanlumretuzumabPaclitaxelpertuzumabReceptor, ErbB-3BiomarkerErbB3Heregulin (HRG)Human epidermal growth factor receptor 2 (HER2)Human epidermal growth factor receptor 3 (HER3)Metastatic breast cancerPertuzumabPhase I

Identifiers

PMID29349598
PMCPMC6153514
OpenAlexW2789217841

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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.