Spots Global Cancer Trial Database for Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
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Trial Identification
Brief Title: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Official Title: CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Study ID: NCT05452213
Interventions
Study Description
Brief Summary: This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.
Detailed Description: This is a prospective, multicenter, phase IV, one-arm, open-label clinical trial investigating patients treated with ribociclib and standard of care endocrine therapy for hormone receptor positive (HR+) / human epidermal growth factor receptor negative (HER2-) advanced breast cancer in the first therapy line. Patients eligible for this trial will receive on-label ribociclib according to Summary of Product Characteristics (SmPC) and as well as the specified inclusion/exclusion criteria. The survival rates for progression-free survival (PFS) and overall survival (OS) at month 12 are the co-primary objectives. Quality of life and toxicity are secondary objectives. Additionally, there is a comprehensive biomarker discovery and validation program included into the study. A total of 1000 patients are planned to be enrolled into this trial in 75 trial sites in Germany. Biomarkers will be evaluated before, during and after treatment or at progression. A comprehensive biospecimens sampling will be done to enable translational research projects and evaluation of potential biomarkers within circulation tumor desoxyribonucleic acid (ctDNA), circulating tumor ribonucleic acid (ctRNA), formaldehyde-fixed paraffin-embedded tissue (FFPE) tissue, Serum, Plasma and circulating immune cells
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen, Bavaria, Germany
Department of Gynecology and Obstetrics, University Medicine Mainz, Mainz, Hesse, Germany
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH, Bottrop, North Rhine-Westphalia, Germany
Klinikum St Marien Amberg, Amberg, , Germany
Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg, Aschaffenburg, , Germany
Klinik für Hämatologie und Onkologie, Uniklinik Augsburg, Augsburg, , Germany
University Hospital Augsburg, Augsburg, , Germany
Frauenklinik des Klinikums Bamberg, Bamberg, , Germany
MediOnko GbR, Berlin, , Germany
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik, Bonn, , Germany
Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte, Bremen, , Germany
Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe, Chemnitz, , Germany
Kliniken Der Stadt Köln gGmbH, Cologne, , Germany
Carl-Thiem-Klinikum Cottbus, Cottbus, , Germany
Staedtisches Klinikum Dessau, Gynecology and Obstetrics, Dessau, , Germany
Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden, Dresden, , Germany
Universitaetsklinikum Duesseldorf AöR, Duesseldorf, , Germany
Universitaetsklinikum Essen AöR, Gynecology and Obstetrics, Essen, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics, Frankfurt Am Main, , Germany
Universitäts-Frauenklinik Frankfurt, Frankfurt am Main, , Germany
Universitäts-Frauenklinik Freiburg, Freiburg, , Germany
Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche, Georgsmarienhütte, , Germany
Universitäts-Frauenklinik Hamburg-Eppendorf, Hamburg, , Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe, Heidelberg, , Germany
Frauenklinik, SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics, Karlsruhe, , Germany
University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics, Kiel, , Germany
ZAGO-Zentrum für ambulante gynäkologische Onkologie, Krefeld, , Germany
Klinikum Kulmbach, Kulmbach, , Germany
VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf, Landshut, , Germany
Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms, Leer, , Germany
Universitäts-Frauenklinik Leipzig, Leipzig, , Germany
Hämatologie Onkologie Gemeinschaftspraxis Pasing, Munich, , Germany
Ev. Krankenhaus Bethesda Mönchengladbach, Mönchengladbach, , Germany
MVZ Nordhausen gGmbH, Nordhausen, , Germany
Klinikum Nürnberg, Nuremberg, , Germany
Frauenklinik, Medius Klinik Nürtingen, Nürtingen, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie GbR, Ravensburg, , Germany
Frauenklinik, Diakoniekrankenhaus Rotenburg, Rotenburg, , Germany
Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH, Schweinfurt, , Germany
Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik, Singen, , Germany
Onkologische Schwerpunktpraxis Speyer, Speyer, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie, Troisdorf, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Universitäts-Frauenklinik Ulm, Ulm, , Germany
MVZ Nordoberpfalz, Weiden, , Germany
Medizinische Studiengesellschaft Nord-West GmbH, Westerstede, , Germany
Rems-Murr Kliniken Winnenden, Winnenden, , Germany
Contact Details
Name: Peter A. Fasching, MD, Prof.
Affiliation: Department of Gynecology and Obstetrics, Erlangen University Hospital
Role: STUDY_CHAIR
Name: Tanja Fehm, MD, Prof.
Affiliation: Department of Gynecology/Obstetrics |University Hospital Düsseldorf, Germany
Role: STUDY_CHAIR
Name: Andreas Schneeweiss, MD, Prof.
Affiliation: National Center for Tumor Diseases (NCT) | Heidelberg University Hospital and German Cancer Research Center
Role: STUDY_CHAIR
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