Schneeweiss, Andreas
Fasching, Peter A.
Thill, Marc
van Mackelenbergh, Marion
Marme, Frederik
Tesch, Hans
Fehm, Tanja N.
Park-Simon, Tjoung-Won
Häberle, Lothar
Uhrig, Sabrina
Tome, Oliver
Spall, Thomas
Theuser, Anna-Katharin
Ruebner, Matthias
Belleville, Erik
Wallwiener, Diethelm
Brucker, Sara Y.
Hartkopf, Andreas D.
Funding for this research was provided by:
Universitätsklinikum Erlangen
Article History
Received: 13 February 2025
Accepted: 10 June 2025
First Online: 19 June 2025
Declarations
:
: SERAPHINA (Safety, Efficacy And Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With nab-Paclitaxel in Daily Routine; NCT02642406) was a single arm, non-interventional study that recruited across 76 study sites in Germany. The study was conducted in accordance with the Declaration of Helsinki and the Guidelines of the International Conference on Harmonization Good Clinical Practice (GCP). Approval of all respective ethics committees were obtained (initial approval obtained from the Ethical Committee of the Medical Faculty of the Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany: date August 12 2015, approval number 193_15B) and all patients provided written informed consent.
: All study participants provided written informed consent before study inclusion.
: Not applicable. Personalized or identifiable data is not part of this manuscript.
: A.S. received research grants from Celgene, Roche, honoraria from Amgen, AstraZeneca, Aurikamed, Bayer, Celgene, Clinsol, Connectmedica, Gilead, GSK, I-MED, Lilly, MCI Deutschland, Metaplan, MSD, Nanostring, Novartis, Onkowissen.de, Promedicis, Pfizer, Pierre Fabre, Roche, Seagen, Streamedup, Teva, Tesaro, Thieme and travel support from Celgene, Pfizer, Roche. P.A.F. reports personal fees from Novartis, grants from Biontech, personal fees from Pfizer, personal fees from Daiichi-Sankyo, personal fees from Astra Zeneca, personal fees from Eisai, personal fees from Merck Sharp & Dohme, grants from Cepheid, personal fees from Lilly, personal fees from Pierre Fabre, personal fees from SeaGen, personal fees from Roche, personal fees from Hexal, personal fees from Agendia, personal fees from Gilead. M.T. has participated on advisory boards for AstraZeneca, Celgene, Clovis, Daiichi Sanyo, Eisai, Gilead Science, Grünenthal, GSK, Lilly, MSD, Novartis, Organon, Pfizer, Pierre-Fabre, Seagen and Roche and has received honoraria for lectures from Amgen, Aurikamed, Celgene, Clovis, Daiichi Sankyo, Eisai, GSK, Lilly, MSD, Roche, Novartis, Organon, Pfizer, Seagen, Exact Sciences, Viatris, Vifor and AstraZeneca and has received trial funding by Exact Sciences and Endomag Manuscript support was done by Amgen, ClearCut, pfm medical, Roche, Servier, Vifor. H.T. received honoraria from Novartis, Roche, Celgene, TEVA, Pfizer, Astra Zeneca and travel support from Roche, Celgene and Pfizer. T.N.F. has participated on advisory boards for Amgen, Daiichi Sankyo, Novartis, Pfizer, and Roche and has received honoraria for lectures from Amgen, Celgene, Daiichi Sankyo, Roche, Novartis and Pfizer. T.W.P.-S. received honoraria from Roche, AstraZeneca, Daiichi-Sankyo, Eisai, Exact Sciences, Gilead, GSK, MSD, NCO, Novartis, Onkowissen, ONKO-Internetportal, Pfizer, Roche, Seagen, and Thieme. T.S. received honoraria from Gilead, Ipsen, Sanofi, Sandoz, SunPharma, AstraZeneca, Novartis, Hexal, BMS, Lilly, Pfizer, Roche, MSD, BBraun and onkowissen.de for clinical research management and/or medical education activities. E.B. received honoraria from Gilead, Ipsen, Sanofi, Sandoz, SunPharma, AstraZeneca, Novartis, Hexal, BMS, Lilly, Pfizer, Roche, MSD, BBraun and onkowissen.de for clinical research management and/or medical education activities. S.Y.B. received honoraria from Roche, Novartis, Pfizer, AstraZeneca, Lilly, MSD and Hologic. A.D.H. received speaker and consultancy honoraria from AstraZeneca, Genomic Health, Roche, Novartis, Celgene, Lilly, MSD, Eisai, Teva, Tesaro, Daiichi-Sankyo, Hexal and Pfizer. All remaining authors have nothing to disclose.