Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Rachel A FreedmanNancy U Lin

Abstract

Evidence-based treatments for metastatic, human epidermal growth factor receptor 2 (HER2)-positive breast cancer in the CNS are limited. Neratinib is an irreversible inhibitor of erbB1, HER2, and erbB4, with promising activity in HER2-positive breast cancer; however, its activity in the CNS is unknown. We evaluated the efficacy of treatment with neratinib in patients with HER2-positive breast cancer brain metastases in a multicenter, phase II open-label trial. Eligible patients were those with HER2-positive brain metastases (≥ 1 cm in longest dimension) who experienced progression in the CNS after one or more line of CNS-directed therapy, such as whole-brain radiotherapy, stereotactic radiosurgery, and/or surgical resection. Patients received neratinib 240 mg orally once per day, and tumors were assessed every two cycles. The primary endpoint was composite CNS objective response rate (ORR), requiring all of the following: ≥ 50% reduction in volumetric sum of target CNS lesions and no progression of non-target lesions, new lesions, escalating corticosteroids, progressive neurologic signs/symptoms, or non-CNS progression--the threshold for success was five of 40 responders. Forty patients were enrolled between February 2012 and J...Continue Reading

Associated Clinical Trials

References

Jul 1, 1990·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·D R MacdonaldJ G Cairncross
Aug 1, 1993·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·M A SprangersN K Aaronson
Dec 1, 1996·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·M T King
Oct 16, 2002·International Journal of Radiation Oncology, Biology, Physics·Ashraf S Mahmoud-AhmedGene H Barnett
Jan 1, 1996·Archives of Clinical Neuropsychology : the Official Journal of the National Academy of Neuropsychologists·R M RuffH S Levin
Jan 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Christina A MeyersMarkus F Renschler
Mar 11, 2004·Archives of Clinical Neuropsychology : the Official Journal of the National Academy of Neuropsychologists·Tom N Tombaugh
Aug 20, 2004·The New England Journal of Medicine·Massimo CristofanilliDaniel F Hayes
Sep 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nancy U LinEric P Winer
Oct 27, 2004·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·W Jeffrey AllardLeon W M M Terstappen
Feb 10, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Sabine RiethdorfKlaus Pantel
Mar 17, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Nancy U Lin, Eric P Winer
Apr 19, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nancy U LinEric P Winer
Jul 5, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Kim CocksJulia M Brown
Dec 19, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·L H SchwartzE A Eisenhauer
Dec 23, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E A EisenhauerJ Verweij
Feb 21, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Nancy U LinEric P Winer
Mar 26, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Kwok-K WongHoward A Burris
May 1, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·B C Pestalozzi
Feb 10, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Harold J BursteinRajendra Badwe
May 26, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hagen KenneckeKaren Gelmon
May 12, 2011·Neuro-oncology·Jeffrey S WefelHenry S Friedman
Dec 29, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paul W SperdutoMinesh Mehta
Jan 29, 2013·The Breast : Official Journal of the European Society of Mastology·Erin M OlsonNancy U Lin
Aug 21, 2013·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Miguel MartinAhmad Awada
Sep 10, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J-Y PiergaT Bachelot
Oct 9, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Antonio C WolffUNKNOWN College of American Pathologists
Jun 4, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jeffrey B SmerageDaniel F Hayes
Jun 13, 2015·The Lancet Oncology·Nancy U LinUNKNOWN Response Assessment in Neuro-Oncology (RANO) group

❮ Previous
Next ❯

Citations

Jul 14, 2016·Clinical Breast Cancer·Shruti Rakesh TiwariJame Abraham
Jul 7, 2016·Neuro-oncology·Nils D ArvoldPatrick Y Wen
Jul 15, 2016·Journal of Medicinal Chemistry·Timothy P Heffron
Sep 21, 2016·International Journal of Molecular Sciences·Vyshak Alva Venur, José Pablo Leone
Oct 4, 2016·Expert Opinion on Pharmacotherapy·Annemie Prové, Luc Dirix
Mar 23, 2017·Current Neurology and Neuroscience Reports·Nicole ShonkaManmeet S Ahluwalia
Jun 27, 2017·Expert Review of Anticancer Therapy·Isabel EchavarriaMiguel Martin
Jul 1, 2017·Future Oncology·Mathew A Cherian, Cynthia X Ma
Jul 12, 2017·Expert Opinion on Drug Safety·Samuel MartelEvandro De Azambuja
Mar 23, 2018·Neuro-oncology·Rute M S M PedrosaJohan M Kros
Oct 3, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nancy U LinEdward S Kim
Aug 8, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Amy Jo Chien, Hope S Rugo
Jun 30, 2018·Future Oncology·Riccardo SoffiettiRoberta Rudà
Jan 5, 2019·The Annals of Pharmacotherapy·Rutugandha ParanjpeMeghana V Trivedi
Mar 13, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rachel A FreedmanUNKNOWN Translational Breast Cancer Research Consortium
Mar 16, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Sara A Hurvitz
Feb 9, 2018·Nature·David M HymanDavid B Solit
Feb 17, 2018·Therapeutic Advances in Medical Oncology·Rodica Di Lorenzo, Manmeet S Ahluwalia
Apr 9, 2019·Current Oncology Reports·José Pablo Leone, Nancy U Lin
Jun 7, 2019·Breast Cancer Research and Treatment·Michelle E MeliskoHope S Rugo
Aug 9, 2017·Current Opinion in Oncology·Vyshak A Venur, Manmeet S Ahluwalia
Jun 1, 2017·American Society of Clinical Oncology Educational Book·Nancy U LinRiccardo Soffietti
Jun 2, 2016·American Society of Clinical Oncology Educational Book·Vyshak A Venur, Manmeet S Ahluwalia
Jun 1, 2017·American Society of Clinical Oncology Educational Book·Ingrid A MayerSherene Loi
Jan 19, 2019·Nature Reviews. Disease Primers·Achal Singh AchrolSteven D Chang
Oct 17, 2019·Cold Spring Harbor Perspectives in Medicine·Krutika DeshpandeJosh Neman
Oct 18, 2016·Current Opinion in Oncology·Roberta RudàRiccardo Soffietti
Jul 24, 2020·Expert Opinion on Investigational Drugs·Rupert Bartsch
Dec 23, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paul D BrownVinai Gondi
Jul 9, 2020·Therapeutic Advances in Medical Oncology·Jae Sik Kim, In Ah Kim
Aug 15, 2020·Neuro-oncology Advances·Joshua D PalmerDavid Roberge
Aug 31, 2020·Expert Review of Anticancer Therapy·Mafalda OliveiraCristina Saura
Jun 9, 2018·Frontiers in Oncology·Federica FranchinoRiccardo Soffietti
Jul 7, 2018·Therapeutic Advances in Medical Oncology·Nuria KoteckiAhmad Awada
Sep 21, 2018·American Society of Clinical Oncology Educational Book·Jane Lowe MeiselLisa Carey
Nov 27, 2018·F1000Research·Rupesh KotechaMinesh P Mehta

❮ Previous
Next ❯

Related Concepts

Related Feeds

Breast Invasive Carcinoma

Invasive breast cancers indicate a spread into breast tissues and lymph nodes. Here are the latest discoveries pertaining to breast invasive carcinomas.

Breast Invasive Carcinoma (Keystone)

Invasive breast cancers indicate a spread into breast tissues and lymph nodes. Here are the latest discoveries pertaining to breast invasive carcinomas.