Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (ADAPTcycle)

May 12, 2023 updated by: West German Study Group

Adjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Endocrine Therapy Plus Ribociclib Versus Chemotherapy in Intermediate Risk, HR+/HER2- Early Breast Cancer

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The WSG ADAPT trial program is one of the first new generation trials addressing the issue of individualization of (neo)-adjuvant decision-making in early breast cancer (EBC) in a subtype-specific manner. The first WSG ADAPT umbrella trial (NCT01779206) aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment.

The goals of the WSG ADAPT trial program - early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit - have contributed to the very positive national and international feedback to the ADAPT concept as a whole.

The aim of this ADAPTcycle phase-III-trial is to investigate whether the intermediate-risk patient group identified during the screening phase derives additional benefit from treatment with ribociclib in combination with ET compared to chemotherapy (followed by adjuvant ET).

Study Type

Interventional

Enrollment (Anticipated)

1670

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Berlin, Klinik für Gynäkologie m.S. Senologie Brustzentrum (CCM)
        • Principal Investigator:
          • Jens Uwe Blohmer, Prof. Dr.
        • Sub-Investigator:
          • Caroline Neeb, Dr.
        • Contact:
          • Jens Uwe Blohmer, Prof. Dr.
        • Contact:
          • Caroline Neeb, Dr.
      • Berlin, Germany, 10713
        • Recruiting
        • St. Gertrauden Krankenhaus Brustzentrum City Berlin
        • Principal Investigator:
          • Lidia Perlova-Griff
        • Sub-Investigator:
          • Gerd Graffunder, Dr.
        • Contact:
          • Lidia Perlova-Griff
        • Contact:
          • Gerd Graffunder, Dr.
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum Am Urban Brustzentrum
        • Principal Investigator:
          • Claudia Gerber-Schäfer, Dr.
        • Sub-Investigator:
          • Sirrka Kluge, Dr.
        • Contact:
          • Claudia Gerber-Schäfer, Dr.
        • Contact:
          • Sirrka Kluge, Dr.
      • Berlin, Germany, 12559
        • Recruiting
        • DRK Klinikum Berlin-Köpenick Brustzentrum
        • Contact:
          • Anke Kleine-Tebbe, Dr.
        • Principal Investigator:
          • Anke Kleine-Tebbe, Dr.
        • Sub-Investigator:
          • Olaf Pirsig, Dr.
        • Contact:
          • Olaf Pirsig, Dr.
      • Berlin, Germany, 13589
        • Recruiting
        • Evangelisches Waldkrankenhaus Spandau Klinik für Gynäkologie und Geburtshilfe
        • Contact:
          • Silke Polata, Dr.
        • Principal Investigator:
          • Silke Polata, Dr.
        • Sub-Investigator:
          • Sonja Cárdenas-Ovalle, Dr.
        • Contact:
          • Sonja Cárdenas-Ovalle, Dr.
      • Bremen, Germany, 28209
        • Recruiting
        • Hämatologisch/Onkologische Schwerpunktpraxis Praxis Dr. Schreiber
        • Contact:
          • Carsten Schreiber, Dr.
        • Principal Investigator:
          • Carsten Schreiber, Dr.
        • Sub-Investigator:
          • Ralf Meyer, Dr.
        • Contact:
          • Ralf Meyer, Dr.
      • Hamburg, Germany, 20357
        • Recruiting
        • Mammazentrum Hamburg am Krankenhaus Jerusalem
        • Principal Investigator:
          • Christian Schem, Prof. Dr.
        • Sub-Investigator:
          • Felix Hilpert, Prof. Dr.
        • Contact:
          • Christian Schem, Prof. Dr.
        • Contact:
          • Felix Hilpert, Prof. Dr.
      • Hamburg, Germany, 20246
        • Recruiting
        • UKE Hamburg / Frauenklinik Brustzentrum am UKE
        • Principal Investigator:
          • Lisa Steinhilper, Dr.
        • Sub-Investigator:
          • Volkmar Müller, Prof. Dr.
        • Contact:
          • Lisa Steinhilper, Dr.
        • Contact:
          • Volkmar Müller, Prof. Dr.
      • Hamburg, Germany, 20259
        • Recruiting
        • Agaplesion Diakonieklinikum Hamburg Frauenklinik, Brustzentrum u. Gyn. Tumorzentrum / Gyn. Studienambulanz
        • Principal Investigator:
          • Mustafa Celalettin Ugur, Dr.
        • Sub-Investigator:
          • Theresa Bernard, Dr.
        • Contact:
          • Mustafa Celalettin Ugur, Dr.
        • Contact:
          • Theresa Bernard, Dr.
    • Baden-Württemberg
      • Aalen, Baden-Württemberg, Germany, 73430
        • Recruiting
        • Ost-Alb Klinikum Brustzentrum
        • Principal Investigator:
          • Karsten Gnauert, Dr.
        • Sub-Investigator:
          • Elena Denisjuk, Dr.
        • Contact:
          • Karsten Gnauert, Dr.
        • Contact:
          • Elena Denisjuk, Dr.
      • Baden-Baden, Baden-Württemberg, Germany, 76532
        • Recruiting
        • Stadtklinik Baden-Baden Brustzentrum
        • Principal Investigator:
          • Antje Hahn, Dr.
        • Sub-Investigator:
          • Uwe Cramer, Dr.
        • Contact:
          • Antje Hahn, Dr.
        • Contact:
          • Uwe Cramer, Dr.
      • Böblingen, Baden-Württemberg, Germany, 71032
        • Recruiting
        • Kreiskliniken Böblingen Klinikum Böblingen Frauenklinik
        • Contact:
          • Grischa Wachsmann, Dr.
        • Principal Investigator:
          • Grischa Wachsmann, Dr.
        • Sub-Investigator:
          • Stefan Renner, Prof. Dr.
        • Contact:
          • Stefan Renner, Prof. Dr.
      • Esslingen, Baden-Württemberg, Germany, 73730
        • Recruiting
        • Klinikum Esslingen Klinikum für Frauenheilkunde und Geburtshilfe
        • Contact:
          • Thorsten Kühn, Prof. Dr.
        • Principal Investigator:
          • Thorsten Kühn, Prof. Dr.
        • Sub-Investigator:
          • Cornelia Kurz, Prof. Dr.
        • Contact:
          • Cornelia Kurz, Prof. Dr.
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Recruiting
        • Uniklinikum Freiburg Frauenklinik
        • Principal Investigator:
          • Beate Rautenberg, Dr.
        • Sub-Investigator:
          • Thalia Erbes, Dr.
        • Contact:
          • Beate Rautenberg, Dr.
        • Contact:
          • Thalia Erbes, Dr.
      • Freiburg, Baden-Württemberg, Germany, 79110
        • Recruiting
        • Praxis für interdisziplinäre Onkologie & Hämatologie GbR Praxis am Diakonieklinikum
        • Principal Investigator:
          • Matthias Zaiss, Dr.
        • Sub-Investigator:
          • Norbert Marschner, Dr.
        • Contact:
          • Matthias Zaiss, Dr.
        • Contact:
          • Norbert Marschner, Dr.
      • Heilbronn, Baden-Württemberg, Germany, 74078
        • Recruiting
        • SLK-Kliniken-Heilbronn Frauenklinik
        • Principal Investigator:
          • Beatrix Janke
        • Sub-Investigator:
          • Nadine Michel
        • Contact:
          • Beatrix Janke
        • Contact:
          • Nadine Michel
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Recruiting
        • Klinikum Ludwigsburg Klinik für Frauenheilkunde u. Geburtshilfe
        • Principal Investigator:
          • Claudia Hänle, Dr.
        • Sub-Investigator:
          • Wolfgang Heyl, Prof. Dr.
        • Contact:
          • Claudia Hänle, Dr.
        • Contact:
          • Wolfgang Heyl, Prof. Dr.
      • Tübingen, Baden-Württemberg, Germany, 72016
        • Recruiting
        • Universitätsklinikum Tübingen Universitäts-Frauenklinik
        • Principal Investigator:
          • Eva-Maria Grischke, Prof. Dr.
        • Sub-Investigator:
          • Tobias Engler, Dr.
        • Contact:
          • Eva-Maria Grischke, Prof. Dr.
        • Contact:
          • Tobias Engler, Dr.
      • Ulm, Baden-Württemberg, Germany, 89075
        • Recruiting
        • Universitätsfrauenklinik Ulm Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Kristina Veselinovic, Dr.
        • Sub-Investigator:
          • Elena Leinert, Dr.
        • Contact:
          • Kristina Veselinovic, Dr.
        • Contact:
          • Elena Leinert, Dr.
      • Weinheim, Baden-Württemberg, Germany, 69469
        • Recruiting
        • GRN Klinik Weinheim Gynäkologie
        • Principal Investigator:
          • Lelia Bauer, Dr.
        • Sub-Investigator:
          • Bettina Müller, Dr.
        • Contact:
          • Lelia Bauer, Dr.
        • Contact:
          • Bettina Müller, Dr.
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitätsklinik Erlangen Frauenklinik
        • Principal Investigator:
          • Peter Fasching, Prof. Dr.
        • Sub-Investigator:
          • Felix Heindl, Dr.
        • Contact:
          • Peter Fasching, Prof. Dr.
        • Contact:
          • Felix Heindl, Dr.
      • Munich, Bavaria, Germany, 80337
        • Recruiting
        • Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum
        • Contact:
          • Nadia Harbeck, Prof. Dr.
        • Principal Investigator:
          • Nadia Harbeck, Prof. Dr.
        • Sub-Investigator:
          • Rachel Würstlein, Prof. Dr.
        • Contact:
          • Rachel Würstlein, Dr.
      • München, Bavaria, Germany, 80637
        • Recruiting
        • Rotkreuzkliniken München Frauenklinik - Gynäkologie
        • Principal Investigator:
          • Michael Braun, Prof. Dr.
        • Sub-Investigator:
          • Claus Hanusch, Dr.
        • Contact:
          • Michael Braun, Prof. Dr.
        • Contact:
          • Claus Hanusch, Dr.
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Frauenklinik und Poliklinik / Studienzentrale Josef-Schneider-Straße 4
        • Contact:
          • Mithun Scheytt, Dr.
        • Principal Investigator:
          • Achim Wöckel, Prof. Dr.
        • Sub-Investigator:
          • Mithun Scheytt, Dr.
        • Contact:
          • Achim Wöckel, Prof. Dr.
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • Recruiting
        • Carl-Thiem-Klinikum / Brustzentrum Senologie der Frauenklinik
        • Contact:
          • Nikola Bangemann, Dr.
        • Principal Investigator:
          • Nikola Bangemann, Dr.
        • Sub-Investigator:
          • Juliane Bock
        • Contact:
          • Juliane Bock
      • Fürstenwalde, Brandenburg, Germany, 15517
        • Recruiting
        • Schwerpunktpraxis Gynäkologische Onkologie Praxis Dr. Heinrich
        • Contact:
          • Georg Heinrich, Dr.
        • Principal Investigator:
          • Georg Heinrich, Dr.
        • Sub-Investigator:
          • Christine Kanowski, Dr.
        • Contact:
          • Christine Kanowski, Dr.
      • Potsdam, Brandenburg, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann Klinik für Gynäkologie und Geburtshilfe
        • Contact:
          • Dorothea Fischer, Prof. Dr.
        • Principal Investigator:
          • Dorothea Fischer, Prof. Dr.
        • Sub-Investigator:
          • Anja Langer, Dr.
        • Contact:
          • Anja Langer, Dr.
    • Bremen
      • Bremerhaven, Bremen, Germany, 27574
        • Recruiting
        • Klinikum Bremerhaven Reinkenheide Frauenklinik
        • Principal Investigator:
          • Amelie Bletscher
        • Sub-Investigator:
          • Jens Fehr, Dr.
        • Sub-Investigator:
          • Doraid Mouarrawy, MD
        • Contact:
          • Amelie Bletscher
        • Contact:
          • Jens Fehr, Dr.
    • Hesse
      • Frankfurt, Hesse, Germany, 60431
        • Recruiting
        • AGAPLESION Markus Krankenhaus / Brustzentrum Gynäkologie und Geburtshilfe
        • Principal Investigator:
          • Marc Thill, Prof. Dr.
        • Sub-Investigator:
          • Christiane Brandi, Dr.
        • Contact:
          • Marc Thill, Prof. Dr.
        • Contact:
          • Christiane Brandi, Dr.
      • Frankfurt am Main, Hesse, Germany, 65929
        • Recruiting
        • Klinikum Frankfurt Höchst Klinik für Gynäkologie und Geburtshilfe
        • Principal Investigator:
          • Joachim Rom, Prof. Dr.
        • Sub-Investigator:
          • Annette Junker-Stein
        • Contact:
          • Joachim Rom, Prof. Dr.
        • Contact:
          • Annette Junker-Stein
      • Kassel, Hesse, Germany, 34125
        • Recruiting
        • Klinikum Kassel Frauenklinik
        • Principal Investigator:
          • Gabriele Feisel-Schwickardi
        • Sub-Investigator:
          • Lydia Dautzenberg
        • Contact:
          • Gabriele Feisel-Schwickardi
        • Contact:
          • Lydia Dautzenberg
      • Offenbach, Hesse, Germany, 63069
        • Recruiting
        • Sana Klinikum Klinik für Gynäkologie und Geburtshilfe, Studienambulanz AOZ
        • Sub-Investigator:
          • Silvia Khodaverdi, Dr.
        • Principal Investigator:
          • Christian Jackisch, Prof. Dr.
        • Contact:
          • Christian Jackisch, Prof. Dr.
        • Contact:
          • Silvia Khodaverdi, Dr.
      • Wiesbaden, Hesse, Germany, 65189
        • Recruiting
        • St. Josefs-Hospital Wiesbaden Frauenklinik - Gynäkologie
        • Contact:
          • Carolin Hammerle, Dr.
        • Principal Investigator:
          • Antje Lehnert, Dr.
        • Sub-Investigator:
          • Carolin Hammerle, Dr.
        • Contact:
          • Antje Lehnert, Dr.
    • Lower Saxony
      • Braunschweig, Lower Saxony, Germany, 38100
        • Recruiting
        • Frauenärzte Casparistraße Studien GbR BS
        • Principal Investigator:
          • Ralf Lorenz, Dr.
        • Sub-Investigator:
          • Janine Kreiss-Sender, Dr.
        • Contact:
          • Ralf Lorenz, Dr.
        • Contact:
          • Janine Kreiss-Sender, Dr.
      • Georgsmarienhütte, Lower Saxony, Germany, 49124
        • Recruiting
        • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie, Brustzenzrum
        • Principal Investigator:
          • Kerstin Lüdtke-Heckenkamp, Dr.
        • Sub-Investigator:
          • Jost Wamhoff, Dr.
        • Contact:
          • Kerstin Lüdtke-Heckenkamp, Dr.
        • Contact:
          • Jost Wamhoff, Dr.
      • Hannover, Lower Saxony, Germany, 30539
        • Recruiting
        • Medizinische Hochschulle Hannover Klinik für Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Tjoung-Won Park-Simon, Prof. Dr.
        • Sub-Investigator:
          • Elna Kühnle, Dr.
        • Contact:
          • Tjoung-Won Park-Simon, Prof. Dr.
        • Contact:
          • Elna Kühnle, Dr.
      • Hannover, Lower Saxony, Germany, 30559
        • Recruiting
        • Diakovere Henriettenstift Frauenklinik
        • Principal Investigator:
          • Kristina Lübbe, Dr.
        • Contact:
          • Kristina Lübbe, Dr.
      • Hildesheim, Lower Saxony, Germany, 31134
        • Recruiting
        • Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz Klinische Studien
        • Principal Investigator:
          • Christoph Uleer, Dr.
        • Sub-Investigator:
          • Jasmin Pourfard, Dr.
        • Contact:
          • Christoph Uleer, Dr.
        • Contact:
          • Jasmin Pourfard, Dr.
      • Lüneburg, Lower Saxony, Germany, 21339
        • Recruiting
        • Städtisches Klinikum Lüneburg Frauenklinik
        • Principal Investigator:
          • Peter Dall, Prof. Dr.
        • Sub-Investigator:
          • Eric Boetel, Dr.
        • Contact:
          • Peter Dall, Prof. Dr.
        • Contact:
          • Eric Boetel, Dr.
      • Stade, Lower Saxony, Germany, 21680
        • Recruiting
        • MVZ Klinik Dr. Hancken Haematologie/Onkologie
        • Contact:
          • Johannes Meiler, Dr.
        • Principal Investigator:
          • Johannes Meiler, Dr.
        • Sub-Investigator:
          • Kathrin Engelken, Dr.
        • Contact:
          • Kathrin Engelken, Dr.
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • Recruiting
        • UFK Klinikum Südstadt Frauenklinik
        • Principal Investigator:
          • Toralf Reimer, Prof. Dr.
        • Sub-Investigator:
          • Christian George, Dr.
        • Contact:
          • Toralf Reimer, Prof. Dr.
        • Contact:
          • Christian George, Dr.
    • NRW
      • Aachen, NRW, Germany, 52074
        • Recruiting
        • Universitätsklinikum Aachen, Frauenklinik - Senologie
        • Principal Investigator:
          • Katja Krauss, Dr.
        • Sub-Investigator:
          • Elmar Stickeler, Dr.
        • Contact:
          • Katja Krauss, Dr.
        • Contact:
          • Elmar Stickeler, Dr.
      • Aachen, NRW, Germany, 52062
        • Recruiting
        • Marienhospital Praxis Dr. Danaei
        • Principal Investigator:
          • Miriam Kohlschein, Dr.
        • Sub-Investigator:
          • Mahmoud Danaei, Dr.
        • Contact:
          • Miriam Kohlschein, Dr.
        • Contact:
          • Mahmoud Danaei, Dr.
      • Aachen, NRW, Germany, 52066
        • Recruiting
        • Marienhospital Studienzentrale - BrustCentrum Aachen Kreis Heinsberg
        • Principal Investigator:
          • Mahmoud Danaei, Dr.
        • Sub-Investigator:
          • Miriam Kohlschein, Dr.
        • Contact:
          • Miriam Kohlschein, Dr.
        • Contact:
          • Mahmoud Danaei, Dr.
      • Bergisch-Gladbach, NRW, Germany, 51465
        • Recruiting
        • EVK Bergisch Gladbach Brustzentrum
        • Principal Investigator:
          • Lena Leitzen
        • Sub-Investigator:
          • Nina Beermann, Dr.
        • Contact:
          • Lena Leitzen
        • Contact:
          • Nina Beermann, Dr.
      • Bielefeld, NRW, Germany, 33604
        • Recruiting
        • Onkologische Schwerpunktpraxis Bielefeld Praxis Dr. Just
        • Contact:
          • Marianne Just, Dr.
        • Principal Investigator:
          • Marianne Just, Dr.
        • Sub-Investigator:
          • Siemke Steinke, Dr.
        • Contact:
          • Siemke Steinke, Dr.
      • Bottrop, NRW, Germany, 46236
        • Recruiting
        • Marienhospital Bottrop Klinik für Gynäkologie und Geburtshilfe / Gyn-Ambulanz
        • Principal Investigator:
          • Hans Christian Kolberg, PD. Dr.
        • Sub-Investigator:
          • Abdrhman Maguz
        • Contact:
          • Hans Christian Kolberg, PD. Dr.
        • Contact:
          • Abdrhman Maguz
      • Cologne, NRW, Germany, 50935
        • Recruiting
        • St. Elisabeth-Krankenhaus Hohenlind Brustzentrum
        • Principal Investigator:
          • Claudia Schumacher, Dr.
        • Contact:
          • Claudia Schumacher, Dr.
      • Cologne, NRW, Germany, 50937
        • Recruiting
        • Uniklinik Köln / Gebäude 70 Studienzentrale der Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Wolfram Malter, Dr.
        • Sub-Investigator:
          • Julian Puppe, Dr.
        • Contact:
          • Wolfram Malter, Dr.
        • Contact:
          • Julian Puppe, Dr.
      • Cologne, NRW, Germany, 51067
        • Recruiting
        • Kliniken der Stadt Köln / Krankenhaus Holweide Brustzentrum Holweide
        • Principal Investigator:
          • Myriam Vincent
        • Sub-Investigator:
          • Ilka Bernhöft, Dr.
        • Contact:
          • Myriam Vincent
        • Contact:
          • Ilka Bernhöft, Dr.
      • Dortmund, NRW, Germany, 44137
        • Recruiting
        • Klinikum Dortmund gGmbH Frauenklinik
        • Principal Investigator:
          • Claudia Biehl
        • Sub-Investigator:
          • Jenci Palatty
        • Contact:
          • Claudia Biehl
        • Contact:
          • Jenci Palatty
      • Düsseldorf, NRW, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf Klinik für Frauenheilkunde & Geburtshilfe
        • Principal Investigator:
          • Tanja Fehm, Prof. Dr.
        • Sub-Investigator:
          • Eugen Ruckhäberle, Prof. Dr.
        • Contact:
          • Tanja Fehm, Prof. Dr.
        • Contact:
          • Eugen Ruckhäberle, Prof. Dr.
      • Düsseldorf, NRW, Germany, 40235
        • Recruiting
        • Luisenkrankenhaus GmbH GynOnco Düsseldorf
        • Principal Investigator:
          • Athina Kostara, Dr.
        • Sub-Investigator:
          • Maren Darsow, Dr.
        • Contact:
          • Athina Kostara, Dr.
        • Contact:
          • Maren Darsow, Dr.
      • Erkelenz, NRW, Germany, 41812
        • Recruiting
        • Praxis Dr. Adhami
        • Principal Investigator:
          • Barmak Adhami, Dr.
        • Sub-Investigator:
          • Brigitte Königs-El Amrawy, Dr.
        • Contact:
          • Barmak Adhami, Dr.
        • Contact:
          • Brigitte Königs-El Amrawy, Dr.
      • Eschweiler, NRW, Germany, 52249
        • Recruiting
        • St. Antonius Hospital Klinik für Hämatologie/Onkologie
        • Principal Investigator:
          • Peter Staib, Prof. Dr.
        • Sub-Investigator:
          • Meike Münchow, Dr.
        • Contact:
          • Peter Staib, Prof. Dr.
        • Contact:
          • Meike Münchow, Dr.
      • Essen, NRW, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum
        • Principal Investigator:
          • Sherko Kümmel, Prof. Dr.
        • Sub-Investigator:
          • Mattea Reinisch, Dr.
        • Contact:
          • Sherko Kümmel, Prof. Dr.
        • Contact:
          • Mattea Reinisch, Dr.
      • Essen, NRW, Germany, 45130
        • Recruiting
        • Universitätsklinikum Essen Klinik für Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Oliver Hoffmann, PD. Dr.
        • Sub-Investigator:
          • Ann-Kathrin Bittner, Dr.
        • Contact:
          • Oliver Hoffmann, PD. Dr.
        • Contact:
          • Ann-Kathrin Bittner, Dr.
      • Gelsenkirchen, NRW, Germany, 45879
        • Recruiting
        • Evangelische Kliniken Gelsenkirchen GmbH Klinik für Senologie
        • Principal Investigator:
          • Hans Holger Fischer
        • Sub-Investigator:
          • Abdallah abdallah@evk-ge.de, Dr.
        • Contact:
          • Hans Holger Fischer
        • Contact:
          • Abdallah Abdallah, Dr.
      • Goch, NRW, Germany, 47574
        • Recruiting
        • Wilhelm-Anton-Hospital Goch Klinik für Innere Medizin, Hämatologie u. Onkologie
        • Contact:
          • Volker Runde, Prof. Dr.
        • Principal Investigator:
          • Volker Runde, Prof. Dr.
        • Sub-Investigator:
          • Jörn Volker, Dr.
        • Contact:
          • Jörn Westheider, Dr.
      • Gütersloh, NRW, Germany, 33332
        • Recruiting
        • Onkodok GmbH
        • Principal Investigator:
          • Reinhard Depenbusch, Dr.
        • Sub-Investigator:
          • Philipp Schütt, PD. Dr.
        • Contact:
          • Reinhard Depenbusch, Dr.
        • Contact:
          • Philipp Schütt, PD. Dr.
      • Hamm, NRW, Germany, 59073
        • Recruiting
        • St. Barbara Klinik Brustzentrum
        • Principal Investigator:
          • Claudia Strunk, Dr.
        • Sub-Investigator:
          • Badur Wlodzimierz, Dr.
        • Contact:
          • Claudia Strunk, Dr.
        • Contact:
          • Badur Wlodzimierz, Dr.
      • Leverkusen, NRW, Germany, 51375
        • Recruiting
        • Klinikum Leverkusen Medizinische Klinik 3
        • Contact:
          • Andrea Heider, Dr.
        • Principal Investigator:
          • Andrea Heider, Dr.
        • Sub-Investigator:
          • Dagmar dagmar
        • Contact:
          • Dagmar Sent
      • Moenchengladbach, NRW, Germany, 41061
        • Recruiting
        • Praxis für gynäkologische Onkologie am Ev. Krankenhaus Bethesda
        • Principal Investigator:
          • Oleg Gluz, PD. Dr.
        • Sub-Investigator:
          • Raquel von Schumann, Dr.
        • Contact:
          • Oleg Gluz, PD. Dr.
        • Contact:
          • Raquel von Schumann, Dr.
      • Münster, NRW, Germany, 48145
        • Recruiting
        • St. Franziskus-Hospital Brustzentrum
        • Principal Investigator:
          • Corina Neumann
        • Sub-Investigator:
          • Stefanie Wiebe, Dr.
        • Contact:
          • Corina Neumann
        • Contact:
          • Stefanie Wiebe, Dr.
      • Münster, NRW, Germany, 48149
        • Recruiting
        • Universitätsklinikum Frauenheilkunde
        • Principal Investigator:
          • Joke Tio, Dr.
        • Sub-Investigator:
          • Isabel Radke, Dr.
        • Contact:
          • Joke Tio, Dr.
        • Contact:
          • Isabel Radke, Dr.
      • Recklinghausen, NRW, Germany, 45659
        • Recruiting
        • ONCOLOGIANOVA Praxis Dr. Emde
        • Contact:
          • Till-Oliver Emde
        • Principal Investigator:
          • Till-Oliver Emde
        • Sub-Investigator:
          • Ludger Heflik, Dr.
        • Contact:
          • Ludger Heflik, Dr.
      • Schwerte, NRW, Germany, 58239
        • Recruiting
        • Marienkrankenhaus Schwerte Brustzentrum
        • Contact:
          • Sarah Wetzig
        • Contact:
          • Michael Hartmann, Dr.
        • Principal Investigator:
          • Sarah Wetzig
        • Sub-Investigator:
          • Michael Hartmann, Dr.
      • Siegen, NRW, Germany, 57072
        • Recruiting
        • Marien-Krankenhaus Klinik für Gynäkologie und Geburtshilfe
        • Principal Investigator:
          • Kristin Baumann, Dr.
        • Sub-Investigator:
          • Badrig Melekian, Dr.
        • Contact:
          • Kristin Baumann, Dr.
        • Contact:
          • Badrig Melekian, Dr.
      • Siegen, NRW, Germany, 57074
        • Recruiting
        • Diakonie Klinikum Jung Stilling Brustzentrum
        • Contact:
          • Volker Müller, Dr.
        • Principal Investigator:
          • Volker Müller, Dr.
        • Sub-Investigator:
          • Vesselina Arnaudov, Dr.
        • Contact:
          • Vesselina Arnaudov, Dr.
      • Troisdorf, NRW, Germany, 53840
        • Recruiting
        • Praxisnetz Hämatologie / internistische Onkologie Praxis Troisdorf
        • Sub-Investigator:
          • Andreas Diel
        • Principal Investigator:
          • Carsten Ziske, Prof. Dr.
        • Contact:
          • Carsten Ziske, Prof. Dr.
        • Contact:
          • Andreas Diel
      • Unna, NRW, Germany, 59423
        • Recruiting
        • Christliches Klinikum Unna gGmbH Brustzentrum
        • Sub-Investigator:
          • Cristin Kühn, Dr.
        • Principal Investigator:
          • Heidi Wortelmann, Dr.
        • Contact:
          • Heidi Wortelmann, Dr.
        • Contact:
          • Cristin Kühn, Dr.
      • Velbert, NRW, Germany, 42551
        • Recruiting
        • Praxis für Hämatologie und internistische Onkologie Praxis Dr. Nusch
        • Principal Investigator:
          • Arnd Nusch, Dr.
        • Sub-Investigator:
          • Werner Langer, Dr.
        • Contact:
          • Arnd Nusch, Dr.
        • Contact:
          • Werner Langer, Dr.
      • Witten, NRW, Germany, 58452
        • Recruiting
        • Marien Hospital / Senologie Brustzentrum
        • Principal Investigator:
          • John Hackmann, Dr.
        • Sub-Investigator:
          • Matthias Zeth
        • Contact:
          • Matthias Zeth
        • Contact:
          • John Hackmann, Dr.
      • Wuppertal, NRW, Germany, 42283
        • Recruiting
        • Helios Universitätsklinikum Frauenheilkunde & Geburtshilfe
        • Principal Investigator:
          • Vesna Bjelic-Radisic, PD. Dr.
        • Sub-Investigator:
          • Oliver Schmalz, Dr.
        • Contact:
          • Vesna Bjelic-Radisic, PD. Dr.
        • Contact:
          • Oliver Schmalz, Dr.
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56058
        • Recruiting
        • Praxisklinik für Hämatologie und Onkologie Institu für Versorgungsforschung in der Onkologie
        • Sub-Investigator:
          • Geothy Chakupurakal, Dr.
        • Contact:
          • Rudolf Weide, Prof. Dr.
        • Principal Investigator:
          • Rudolf Weide, Prof. Dr.
        • Sub-Investigator:
          • Christoph van Roye, Dr.
        • Sub-Investigator:
          • Jörg Thomalla, Dr.
        • Sub-Investigator:
          • Christoph Lutz, Dr.
        • Contact:
          • Christoph van Roye, Dr.
      • Koblenz, Rhineland-Palatinate, Germany, 56073
        • Recruiting
        • Katholisches Klinikum Koblenz-Montabaur-Marienhof Koblenz Marienhof Koblenz - Gynäkologie
        • Principal Investigator:
          • Jan Dünnebacke, Dr.
        • Sub-Investigator:
          • Isabelle Seintsch
        • Contact:
          • Jan Dünnebacke, Dr.
        • Contact:
          • Isabelle Seintsch, Dr.
      • Trier, Rhineland-Palatinate, Germany, 54290
        • Recruiting
        • Klinikum Mutterhaus der Borromäerinnen Innere Medizin I / Onkologie
        • Contact:
          • Rolf Mahlberg, Dr.
        • Principal Investigator:
          • Rolf Mahlberg, Dr.
        • Sub-Investigator:
          • Stefan Heidel, Dr.
        • Contact:
          • Stefan Heidel, Dr.
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Recruiting
        • Universitätsklinikum des Saarlandes Frauenklinik
        • Principal Investigator:
          • Erich-Franz Solomayer, Prof. Dr.
        • Sub-Investigator:
          • Lisa Stotz, Dr.
        • Contact:
          • Erich-Franz Solomayer, Prof. Dr.
        • Contact:
          • Lisa Stotz, Dr.
      • Saarlouis, Saarland, Germany, 66740
        • Recruiting
        • DRK Kliniken Saar / Krankenhaus Saarlouis Brustzentrum
        • Principal Investigator:
          • Johannes Bettscheider, Dr.
        • Sub-Investigator:
          • Elke Dennemark
        • Contact:
          • Johannes Bettscheider, Dr.
        • Contact:
          • Elke Dennemark
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz Frauenklinik / Brustzentrum
        • Principal Investigator:
          • Petra Krabisch, Dr.
        • Sub-Investigator:
          • Franziska Stuckert
        • Contact:
          • Franziska Stuckert
        • Contact:
          • Petra Krabisch, Dr.
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitätsklinikum Dresden Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Pauline Wimberger, Prof. Dr.
        • Sub-Investigator:
          • Theresa Link, Dr.
        • Contact:
          • Pauline Wimberger, Prof. Dr.
        • Contact:
          • Theresa Link, Dr.
      • Leipzig, Saxony, Germany, 04015
        • Recruiting
        • Universitätsklinikum Leipzig Gynäkologie und Universitäres Krebszentrum; Klinik und Poliklinik für Frauenheilkunde
        • Principal Investigator:
          • Bahriye Aktas, Prof. Dr.
        • Contact:
          • Bahriye Aktas, Prof. Dr.
        • Sub-Investigator:
          • Susanne Briest, Dr.
        • Contact:
          • Susanne Briest, Dr.
      • Leipzig, Saxony, Germany, 04129
        • Recruiting
        • Kliniken St. Georg Klinik für Gynäkologie und Geburtshilfe
        • Principal Investigator:
          • Uwe Köhler, Prof. Dr.
        • Sub-Investigator:
          • Catrin Frömter, Dr.
        • Contact:
          • Uwe Köhler, Prof. Dr.
        • Contact:
          • Catrin Frömter, Dr.
      • Rodewisch, Saxony, Germany, 08228
        • Recruiting
        • Klinikum Obergöltzsch-Rodewisch Frauenklinik
        • Principal Investigator:
          • Stefanie Strobel, Dr.
        • Sub-Investigator:
          • Barbara Stephan, Dr.
        • Contact:
          • Stefanie Strobel, Dr.
        • Contact:
          • Barbara Stephan, Dr.
    • Saxony-Anhalt
      • Halle / Saale, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • Universitätsklinikum Halle Universitätsklinik für Gynäkologie
        • Principal Investigator:
          • Christoph Thomssen, Prof. Dr.
        • Sub-Investigator:
          • Susanne Barrot, Dr.
        • Contact:
          • Christoph Thomssen, Prof. Dr.
        • Contact:
          • Susanne Barrot, Dr.
      • Salzwedel, Saxony-Anhalt, Germany, 29410
        • Recruiting
        • Altmark-Klinikum Salzwedel Klinik für Frauenheilkunde
        • Principal Investigator:
          • Susanne Kraudelt, Dr.
        • Sub-Investigator:
          • Ina Gunner
        • Contact:
          • Susanne Kraudelt, Dr.
        • Contact:
          • Ina Gunner
      • Stendal, Saxony-Anhalt, Germany, 39576
        • Recruiting
        • Johanniter Frauenklinik Stendal Gynäkologie
        • Contact:
          • Andrea Stefek, Dr.
        • Principal Investigator:
          • Andrea Stefek, Dr.
        • Sub-Investigator:
          • Sylvia Ruth, Dr.
        • Contact:
          • Sylvia Ruth, Dr.
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck, Frauenklinik
        • Principal Investigator:
          • Nana Bündgen, Dr.
        • Sub-Investigator:
          • Henriette Princk, Dr.
        • Contact:
          • Nana Bündgen, Dr.
        • Contact:
          • Henriette Princk, Dr.
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
        • Principal Investigator:
          • Ingo B. Runnebaum, Prof. Dr.
        • Contact:
          • Ingo B. Runnebaum, Prof. Dr.
      • Nordhausen, Thuringia, Germany, 99734
        • Recruiting
        • MVZ Nordhausen Praxis Dr. Andrea Grafe
        • Contact:
          • Andrea Grafe, Dr.
        • Principal Investigator:
          • Andrea Grafe, Dr.
        • Sub-Investigator:
          • Tino Eckert, Dr.
        • Contact:
          • Tino Eckert, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

A. Prior to REGISTRATION in the study:

1. Written informed consent prior to any screening procedures. 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of initiation of (neo)adjuvant study medication

  • patient underwent bilateral oophorectomy, or
  • age ≥ 60, or

  • age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range.

    4b. OR: Pre-menopausal patients:

  • confirmed negative serum pregnancy test (β-hCG) before starting study treatment, or

  • patient has had a hysterectomy. 5. Histologically confirmed diagnosis of primary estrogen-receptor positive and/or progesterone-receptor positive (> 1%) early breast cancer by local laboratory.

    6. Patient has HER2-negative breast cancer defined as

  • a negative in-situ hybridization test or an IHC status of 0, 1+, or 2+,

  • if IHC is 2+, a negative in-situ hybridization (FISH, CISH, or SISH) test is required (based on the most recently analyzed tissue sample and all tested by a local laboratory).

    7. Local therapy of breast cancer (if adjuvant treatment or planned if neoadjuvant treatment) according to current guidelines.

Note: This may include radiotherapy of breast cancer.

B. Prior to RANDOMIZATION in the study 8. No evidence of distant metastasis (confirmed prior to randomization by, preferentially, CT thorax / abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT).

9. Patient has available tumor tissue from diagnostic biopsy. 10. Patient is classified as intermediate risk according to the ADAPT intermediate-risk definition (i) (as follows), or (only in case of missing Oncotype DX or Ki-67 response data), according to the clinical intermediate-risk definition (ii) (as follows).

(i). ADAPT intermediate-risk definition: Patient meets one of the following criteria:

  • c/pN0, RS ≤ 25 with luminal-B-like (Ki-67 ≥20% or G3) or c/pT2-4 without endocrine response (post-endocrine Ki-67 > 10 %)
  • c/pN1, RS ≤ 25 without endocrine response (post-endocrine Ki-67 > 10 %)
  • c/pN0, RS > 25 with luminal-B-like (Ki-67 ≥20% or G3) or c/pT2-4 with endocrine response (Ki-67 ≤ 10 %)
  • c/pN1, RS > 25 with endocrine response (Ki-67 ≤ 10 %)
  • c/pN2-3, RS ≤ 25 with endocrine response (Ki-67 ≤ 10 %). Note: Postmenopausal patients with pT1-2/pN0 disease and RS < 25, as well as premenopausal patients with pT1-2/pN0 disease and RS<16, are recommended to be treated by endocrine therapy alone and not to be randomized (at investigator´s discretion).

(ii). Clinical intermediate-risk definition (ascertained by investigator): Clinical intermediate risk may be ascertained by the investigator prior to randomization if at maximum two of the following three risk factors are present (according to primary diagnosis / 1st sample):

  1. cT2-4
  2. c/pN positive
  3. G3 and / or Ki-67 ≥ 20% Note: Inclusion of a patient according to "clinical intermediate risk" is permitted only in case of missing baseline Oncotype DX® or Ki-67 decrease. In this case, investigators will follow a risk-based, step-wise assessment process.

11. No contraindication for (neo)-adjuvant ET. 12. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 13. Patient has adequate bone marrow and organ function as defined by the following laboratory values:

  • absolute neutrophil count ≥ 1.5 × 109/L,
  • platelets ≥ 100 × 109/L,
  • hemoglobin ≥ 9.0 g/dL,
  • estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula,
  • INR ≤ 1.5,
  • serum creatinine < 1.5 mg/dL,
  • total bilirubin < ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN,
  • aspartate transaminase (AST) < 2.5 × ULN,
  • alanine transaminase (ALT) < 2.5 × ULN. 14. 2-lead-ECG (CANKADO) with:
  • QTcF interval at screening < 450 msec (using Fridericia's correction),

  • mean resting heart rate 50-90 bpm (determined from the ECG). 15. Ability to swallow ribociclib tablets or to administer other study medication, respectively.

    16. Ability to communicate with the investigator and comply with study procedures.

    17. Willing to remain during therapy at the clinical site, as required by the protocol.

Exclusion Criteria:

Patients eligible for inclusion in this study must not meet any of the following criteria:

  1. Patient with distant metastases of breast cancer beyond regional lymph nodes.
  2. Patient has received prior (neo)-adjuvant treatment with chemotherapy, ET, or any CDK4/6 inhibitor for breast cancer.
  3. Patient has received tamoxifen, raloxifene, or aromatase inhibitors (AIs) for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within last 2 years prior to screening.
  4. Patient has received prior neoadjuvant/adjuvant treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin.
  5. Patient with a known hypersensitivity to any of the excipients of ribociclib, ET, or standard-of-care chemotherapy.
  6. Patient with inflammatory breast cancer at screening.
  7. Patient is concurrently using other anti-cancer therapy.
  8. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  9. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis, or otherwise.
  10. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1.
  11. Patient has a concurrent malignancy, or malignancy within 5 years of randomization, or known history of invasive breast cancer.
  12. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small-bowel resection).
  13. Patient has a known history of HIV infection.
  14. Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection.
  15. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator´s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study, or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.).

  16. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:

    • history of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry,
    • documented cardiomyopathy,
    • left ventricular ejection fraction (LVEF) < 50 % as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO),

    • long QT syndrome, family history of idiopathic sudden death, congenital long QT syndrome, or any of the following:

      • risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia,
      • concomitant medications with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug),
      • inability to determine the QTcF interval,
      • clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left-bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II, and 3rd-degree AV block),
      • systolic blood pressure (SBP) > 160 or < 90 mmHg.

  17. Patient is currently receiving any of the following substances, which cannot be discontinued 7 days prior to Cycle 1 Day 1:

    • concomitant medications, herbal supplements, fruits (e.g. grapefruit, pomegranates, pomelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5,
    • medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  18. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
  19. Participation in a prior investigational study within 30 days prior to enrollment or within five half-lives of the investigational product, whichever is longer.
  20. Not able to understand and to comply with study instructions and requirements.
  21. Pregnant or nursing (lactating) woman.

  22. Woman of child-bearing potential defined as woman physiologically capable of becoming pregnant, unless she is using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment:

    • total abstinence (when this is in line with the preferred and usual lifestyle of the patient).
    • female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment.
    • male partner sterilization (at least 6 months prior to study screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.
    • placement of an intrauterine device (IUD).
  23. Use of oral (estrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ribociclib plus ET
Ribociclib 600mg / day over 26 cycles + endocrine treatment of physician´s choice
Drug: Ribociclib 200Mg Oral Tablet
3 x 200 MG per os
Other Names:
  • Kisqali
No Intervention: Standard-of-care chemotherapy
Standard-of-care chemotherapy according to the clinical guidelines, e.g., of the Breast Committee of the German Gynecological Oncology Group (AGO), and regional prescribing information depending on patient's needs for 16-24 weeks,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
invasive disease-free survival (iDFS)
Time Frame: at end of study, on average 5 years after start of treatment
superiority in invasive disease-free survival (iDFS) of ribociclib + ET vs. standard-of-care chemotherapy
at end of study, on average 5 years after start of treatment
distant disease-free survival (dDFS)
Time Frame: at end of study, on average 5 years after start of treatment
distant disease-free survival (dDFS) in the ribociclib + ET-group to demonstrate survival rate >92%
at end of study, on average 5 years after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS) 95 % CI
Time Frame: at end of study, on average 5 years after start of treatment
95 %-confidence interval (CI) for OS in both arms
at end of study, on average 5 years after start of treatment
distant disease-free survival (dDFS) 95 % CI
Time Frame: at end of study, on average 5 years after start of treatment
95 %-confidence interval (CI) for dDFS in both arms
at end of study, on average 5 years after start of treatment
QoL
Time Frame: at end of study, on average 5 years after start of treatment
quality of life (QoL) and correlation to treatment-related symptoms measured by EQ-VAS and triggered symptom questionnaire,
at end of study, on average 5 years after start of treatment
treatment adherence
Time Frame: at end of study, on average 5 years after start of treatment
treatment adherence measured by drug intake compared between treatment arms
at end of study, on average 5 years after start of treatment
pathological complete response (pCR)
Time Frame: at end of study, on average 5 years after start of treatment
Pathological response rate (defined as ypT0/is/ypN0), as well as further definitions (ypT0/ypN0; ypT0/is/any ypN, near pCR (ypT1a/any ypN)), in neoadjuvant treated patients
at end of study, on average 5 years after start of treatment
clinical response rate
Time Frame: at end of study, on average 5 years after start of treatment
clinical response rate (by palpation, ultrasound, and further methods) compared between treatment arms
at end of study, on average 5 years after start of treatment
rate of breast-conservation therapy
Time Frame: at end of study, on average 5 years after start of treatment
prevalence of breast conservation therapy vs. mastectomy compared between treatment arms
at end of study, on average 5 years after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Study Group

Collaborators

Novartis
Genomic Health®, Inc.

Investigators

  • Principal Investigator: Nadia Harbeck, Prof. Dr., Ludwigs-Maximilians-University Munich, Breast Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2019

Primary Completion (Anticipated)

July 31, 2027

Study Completion (Anticipated)

July 31, 2027

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSG-AM08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The sponsor is committed to following high ethical standards for reporting study results, including the timely communication and publication of clinical trial results, whatever their outcome. The sponsor assures that the key design elements of this protocol will be posted on a publicly accessible database, e.g., www.clinicaltrials.gov, before study start.

As part of its commitment to full transparency in publications, the sponsor supports the full disclosure of all funding sources for the study and publications, as well as any actual and potential conflicts of interest of financial and non-financial nature by all authors, including medical writing / editorial support, if applicable.

IPD Sharing Time Frame

Within 1 year after end of study.

IPD Sharing Access Criteria

for regulatory use only

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer Female

Clinical Trials on Ribociclib 200Mg Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe