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ePoster Display

200TiP - ELEANOR: A multi-national, prospective, non-interventional study (NIS) in patients with human epidermal growth factor receptor (HER2) positive, early breast cancer (eBC) observing real-life extended adjuvant treatment with neratinib and concurrent use of the eHealth solution CANKADO

Date

16 Sep 2021

Session

ePoster Display

Presenters

Nadia Harbeck

Citation

Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687

Authors

N. Harbeck1, D. Lüftner2, U. Breitenstein3, C. Jackisch4, V. Müller5, M. Schmidt6, M. Balic7, G. Rinnerthaler8, M. Schwitter9, K. Zaman10, D. Wrobel11, D. Guth12, J. Terhaag13, M. Zaiss14, T. Schinköthe15, R. Bartsch16

Author affiliations

  • 1 Department Of Obstetrics And Gynecology, And Comprehensive Cancer Center, Breast Center, LMU University Hospital, 81377 - Munich/DE
  • 2 Department Of Hematology, Oncology And Cancer Immunology, University Hospital Charitè, Berlin/DE
  • 3 Division Of Oncology, Brust-Zentrum, 8008 - Zurich/CH
  • 4 Department Of Gynecology And Obstretrics, Klinikum Offenbach GmbH, 63069 - Offenbach am Main/DE
  • 5 Department Of Gynecology, University Hospital Hamburg-Eppendorf, 20246 - Hamburg/DE
  • 6 Department Of Obstetrics And Gynecology, University Hospital Mainz, 55131 - Mainz/DE
  • 7 Department Of Internal Medicine, Universitätsklinik Graz, Graz/AT
  • 8 Department Of Internal Medicine Iii With Haematology, Medical Oncology, Haemostaseology, Infectiology And Rheumatology, Oncolig Center, Salzburg Cancer Research Institute - Laboratory For Immunological And Molecular Cancer Research, Paracelsus Medical University, 5020 - Salzburg/AT
  • 9 Oncology Department, Kantonsspital Graubünden, 7000 - Chur/CH
  • 10 Breast Center, CHUV - Centre Hospitalier Universitaire Vaudois, 1011 - Lausanne/CH
  • 11 Frauenklinik, Sozialstiftung Bamberg Klinikum am Bruderwald, 96049 - Bamberg/DE
  • 12 Gyneco-oncological Practice, Praxis Dr.med. Dagmar Guth, 08525 - Plauen/DE
  • 13 Gynecology, Rottal/Inn Clinic, Eggenfelden/DE
  • 14 Praxis Für Interdisziplinäre Onkologie, Praxis Freiburg, 79110 - Freiburg im Breisgau/DE
  • 15 Ehealth, Cancado Service GmbH, 50933 - Köln/DE
  • 16 Department Of Medicine 1, Division Of Oncology, Medizinische Universitaet Wien, 1090 - Vienna/AT
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Abstract 200TiP

Background

The aim of (post-)/(neo)adjuvant chemotherapy and HER2-targeted therapy in HER2+ eBC is to prevent locoregional recurrences and development of distant metastases. Despite significant improvements of long-term clinical outcomes, (late) recurrences are still frequently observed with longer follow-up. Neratinib is an irreversible pan-HER tyrosine kinase inhibitor registered in Europe as extended adjuvant treatment for patients with HR-positive (HR+), HER2+ eBC who completed adjuvant trastuzumab-based therapy ≤1 year before starting neratinib (EMA-/Swissmedic-label” population). In the ExteNET study, neratinib improved the 5-year iDFS-rate by 5.1% versus placebo (90.8% vs. 85.7%; HR 0.58 [95% CI 0.41-0.82]) in this population, mainly by prolonging the time to development of distant metastases. Diarrhea, the most common grade 3 adverse event (neratinib: 39% without primary diarrhea prophylaxis, median cumulative duration 5 days; placebo: 1%; no grade 4 events) can generally be managed through adequate diarrhea prophylaxis and treatment management. ELEANOR is the first NIS to investigate real-world use of neratinib in the modern treatment landscape in the registered population in Germany, Austria and Switzerland. 200 female patients are planned to be documented in accordance with the SmPC.

Trial design

The primary objective is patients’ adherence to neratinib treatment. Secondary objectives include patient and disease characteristics, details on prior trastuzumab-based therapies (including pertuzumab and T-DM1), neratinib doses and concurrent medication, relapses, safety, and quality of life (QoL). CANKADO, an application developed to support patient/physician communication, is an integral part of the NIS. Different CANKADO modules can be used optionally, including QoL documentation (EQ-5D-5L- and diarrhea-specific questionnaires) and continuous documentation of health status and symptoms. As of 2021-05-03, 116 patients had been enrolled at 42 sites, including hospitals and practices.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Pierre Fabre Pharma GmbH Germany; Pierre Fabre Pharma Austria; Pierre Fabre Pharma AG Switzerland.

Funding

Pierre Fabre Pharma GmbH Germany, Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG Switzerland.

Disclosure

N. Harbeck: Financial Interests, Personal, Advisory Role: AstraZeneca ,BMS, Celgene, Daiichi Sankyo, Genomic Health, Eli Lilly, MSD, Novartis, Odonate, Pierre Fabre, Pfizer, Roche, Sandoz/Hexal, Seattle Genetics; Financial Interests, Personal, Other, Lectures: Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seattle Genetics; Financial Interests, Personal, Stocks/Shares, West German Study Group - minority ownership academic study group: WSG; Financial Interests, Institutional, Invited Speaker, all directly to my institution (clinical phase II-IV trials): several sponsors; Financial Interests, Institutional, Sponsor/Funding, clinical phase II-IV trials: several sponsors; Non-Financial Interests, Personal, Leadership Role: AGO breast commission. D. Lüftner: Non-Financial Interests, Personal, Invited Speaker: Amgen, Pierre Fabre, Pfizer, Eli Lilly; Non-Financial Interests, Institutional, Writing Engagements: Pierre Fabre, Novartis, Eli Lilly; Non-Financial Interests, Personal, Speaker’s Bureau: GSK, Loreal, Teva, Amgen, Pfizer, Novartis; Non-Financial Interests, Personal, Advisory Board: Gilead, Sanofi Aventis, Daiichi Sankyo; Non-Financial Interests, Institutional, Research Grant: Novartis; Non-Financial Interests, Institutional, Project Lead: Pierre Fabre; Non-Financial Interests, Personal, Principal Investigator: Pierre Fabre; Non-Financial Interests, Personal, Principal Investigator: Daiichi Sankyo; Non-Financial Interests, Personal, Principal Investigator: Samsung. U. Breitenstein: Financial Interests, Institutional, Invited Speaker: Novartis, Roche, AstraZeneca, Eli Lilly; Financial Interests, Institutional, Advisory Board: Novartis, Roche, AstraZeneca, Eli Lilly; Financial Interests, Institutional, Principal Investigator: Roche, Eli Lilly, Pierre Fabre, Novartis, Pfizer, AstraZeneca, SAKK; Financial Interests, Institutional, Member: SGMO, SGS, SAKK. C. Jackisch: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Eisai, Pfizer, Eli Lilly, Novartis, Exact Sciences, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Eli Lilly, Exact Sciences, Novartis, Pfizer; Non-Financial Interests, Personal, Principal Investigator: Roche. V. Müller: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Daiichi Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, Seattle Genetics; Financial Interests, Personal, Advisory Role: Genomic Health, Hexal, Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, Daiichi Sankyo, Eisai, Eli Lilly, Tesaro, Nektar; Financial Interests, Institutional, Other, research support: Novartis, Roche, Seattle Genetics Genentech. M. Schmidt: Financial Interests, Institutional, Research Grant: Pierre Fabre, Roche, Pfizer, Novartis, AstraZeneca, Eisai, Pantarhei, BioNTech, Genentech; Financial Interests, Personal, Advisory Role: Pierre Fabre, Roche, Pfizer, Novartis, AstraZeneca, Eisai, Amgen, Pantarhei, BioNTech, SeaGen; Non-Financial Interests, Personal, Other: Roche, Pfizer, Pantarhei, BioNTech; Non-Financial Interests, Personal, Other, Issued patent EP: 2951317, Issued patent EP: 2390370: Patent. M. Balic: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Eli Lilly, Novartis, MSD, Pierre Fabre, Pfizer, Roche; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Daiichi Sankyo, Bayer, Eli Lilly, MSD, Novartis, Pfizer, Roche, Samsung, Seagen; Financial Interests, Institutional, Research Grant: Novartis, Eli Lilly, Pfizer, Celgene; Financial Interests, Personal, Funding, Travel/ Accomodation/Expenses: AstraZeneca, Amgen, Bayer, Celgene, Eli Lilly, MSD, Novartis, Pierre Fabre, Roche; Financial Interests, Institutional, Principal Investigator: ABCSG, IBCSG, BIG, AstraZeneca, MSD, Eli Lilly, Roche. G. Rinnerthaler: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Novartis, BMS, Roche, Pfizer, Eli Lilly; Financial Interests, Personal, Advisory Board: Pierre Fabre, MSD, Roche, Novartis, Pfizer, Eli Lilly, Daiichi Sankyo; Financial Interests, Institutional, Funding: Roche. M. Schwitter: Non-Financial Interests, Personal and Institutional, Advisory Board: Pierre Fabre. K. Zaman: Financial Interests, Institutional, Advisory Role: Eli Lilly, Novartis, Roche, SMD Oncology, Mylan, Daiichi Sankyo, Pierre Fabre; Financial Interests, Institutional, Research Grant: Roche/Genentech; Financial Interests, Personal, Other, Travel/ Accomodation/Expenses: Roche; Financial Interests, Institutional, Other, Travel/ Accomodation/Expenses: Pierre Fabre, MSD Oncology, Pierre Fabre. D. Wrobel: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Other: Novartis. M. Zaiss: Financial Interests, Personal, Invited Speaker: AstraZeneca, RG, AKS, Vifor; Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, Pfizer, Janssen, Novartis, AbbVie, Eli Lilly; Financial Interests, Institutional, Principal Investigator: GBG, Eli Lilly, Roche. T. Schinköthe: Financial Interests, Personal, Full or part-time Employment: Cancado; Financial Interests, Personal, Ownership Interest: Cancado. R. Bartsch: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Seagen; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, MSD, Novartis, Pfizer, Pierre Fabre, PUMA, Roche, Seagen; Financial Interests, Institutional, Research Grant: Daiichi Sankyo, MSD; Non-Financial Interests, Institutional, Research Grant: Daiichi Sankyo, MSD; Financial Interests, Institutional, Principal Investigator: ABCSG, Daiichi Sankyo, Eli Lilly, Novartis, Roche; Non-Financial Interests, Personal, Member: ESMO, österreichische Gesellschaft für Senologie, österr. Gesellschaft für Hämatologie und Onkologie. All other authors have declared no conflicts of interest.

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