Consent for publication
Ethics approval and consent to participate
Ethical committee approval from all centers participating in the clinical study and from the Institutional Review Board of Charité University Hospital Berlin (Germany; Ethikvotum EA1/139/05) was obtained. Written consent was obtained from each participant or their proxy. This study was conducted adhering to the REMARK (Reporting Recommendations for Tumor Marker Prognostic Studies) criteria .
Availability of data and materials
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Conflict of interest
V.M: Dr. Möbus received speaker honoraria from Amgen, Astra Zeneca, Celgene, Roche, Teva, and consultancy honoraria from Roche, Amgen, Tesaro and Myelo Therapeutics GmbH.
V.M: Dr. Müller received speaker honoraria from Amgen, Astra Zeneca, Celgene, Daiichi-Sankyo, Eisai, Pfizer, Novartis, Roche, Teva, and consultancy honoraria from Genomic Health, Hexal, Roche, Pierre Fabre, Amgen, Novartis, MSD, Daiichi-Sankyo and Eisai, Lilly, Tesaro and Nektar. Research support from Novartis, Roche, Seattle Genetics, Genentech.
PAF: Dr. Fasching reports grants from Novartis, grants from Biontech, personal fees from Novartis, personal fees from Roche, personal fees from Pfizer, personal fees from Celgene, personal fees from Daiichi-Sankyo, personal fees from Astra Zeneca, personal fees from Macrogenics, personal fees from Eisai, personal fees from Merck Sharp & Dohme, grants from Cepheid, personal fees from Lilly, during the conduct of the study.
ES: Dr. Stickeler reports personal fees from Roche Pharma, personal fees from Novartis, personal fees from Pfizer, personal fees from Tesaro, personal fees from Astra Zeneca, outside the submitted work.
CD: Dr. Denkert received honoraria from Novartis and Roche; Research funding from Myriad Genetics, reports consulting or advisory role for MSD Oncology and Daiichi Sankyo and stock and other ownership interest with Sividon Diagnostics (now Myriad and travel expenses from Roche. In addition, Dr. Denkert has patents, royalities and intellectual property with VMscopedigital pathology software: Patent application: EP18209672 - cancer immunotherapy; Patent application EP20150702464 - therapy response; Patent application EP20150702464 - therapy response.
LH: Dr. Hanker received speaker honoraria from Astra Zeneca, Clovis, GSK/Tesaro Novartis, Roche, and consultancy honoraria from Astra Zeneca, Clovis, GSK/Tesaro and Roche.
FM: Dr. Marmé reports personal fees from Roche, personal fees from AstraZeneca, personal fees from Pfizer, personal fees from Tesaro, personal fees from Novartis, personal fees from Amgen, personal fees from PharmaMar, personal fees from GenomicHealth, personal fees from CureVac, personal fees from EISAI, outside the submitted work.
SL: Dr. Loibl reports grants and other from Abbvie , grants and other from Amgen, grants and other from Astra Zeneca, grants and other from Celgene, grants and other from Novartis, grants and other from Pfizer, grants and other from Roche, other from Seattle Genetics, other from PriME/ Medscape, personal fees from Chugai, grants from Teva, grants from Vifor, grants and other from Daiichi-Sankyo, other from Lilly, other from Samsung, other from Eirgenix, other from BMS, other from Puma, other from MSD, grants from Immunomedics, outside the submitted work; In addition, Dr. Loibl has a patent EP14153692.0 pending.
The other authors (CS; KML; SS; JR; RPH; TK; CS; CHK; LH; US; VV; VN) declare that they have no competing interests.
All authors (CS, VM, KML, SS, PF, JR, ES, RPH, CD, LH, CS, VV, TK, VN, CHK, FM, US, SL, VM) contributed to the study conception and design. VM,SS,PF,JR,ES,RPH,CD,LH,CS,VV,TK,VN,CHK,FM,SL,VM provide patient data for the trial described in the article. Material preparation, data collection and analysis were performed by Karin Milde-Langosch (KML), Christine Stürken (CS), Valentina Vladimirova (VV) and Volkmar Müller (VM). The first draft of the manuscript was written by Christine Stürken (CS) and Karin Milde-Langosch (KML) and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
We are grateful for the excellent technical assistance of Kathrin Eylmann, UKE, Dr. Hanna Taipaleenmäki, UKE for providing the IHC protocol of TGIF and Dr. Bianca Lederer, GBG for preparing the statistical analysis. The authors would like to thank all patients, clinicians, pathologists and the biomaterial collection participating in this clinical study as well as the team at the German Breast Group headquarters.