Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC (ADAPTlate)

February 28, 2024 updated by: West German Study Group

Adj. Dynamic Marker - Adjusted Personalized Therapy Comparing Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy in (Clinical or Genomic) High Risk, HR+/HER2- EBC

Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study. This patient group is currently offered a standard of care chemotherapy plus endocrine therapy (ET). The study investigates whether the patient group with high-risk early breast cancer benefits from treatment with the medication abemaciclib in combination with ET compared to ET alone.

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 positive national and international feedback regarding the ADAPT-concept as a whole.

The aim of this ADAPTlate phase-III-trial is to gain further knowledge of the group of patients at intermediate to high risk for disease recurrence, who have completed definite locoregional therapy (with or without neoadjuvant or adjuvant chemotherapy). With ADAPTlate it is planned to investigate if the intermediate to high-risk patient group identified during the screening phase derives additional benefit from treatment with abemaciclib in combination with ET compared to ET alone.

Study Type

Interventional

Enrollment (Estimated)

1260

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, 10367
        • Recruiting
        • MediOnko-Institut GbR
        • Contact:
          • Peter Klare, Dr. med.
        • Contact:
          • Gläser, Steffen Gläser, Dr. med.
        • Principal Investigator:
          • Peter Klare, Dr. med.
        • Sub-Investigator:
          • Gläser, Steffen Gläser, Dr. med.
      • Berlin, Germany, 10713
        • Recruiting
        • Praxis für gynäkologische Onkologie im Brustzentrum City am Sankt Gertrauden KH
        • Principal Investigator:
          • Lidia Perlova-Griff
        • Contact:
          • Lidia Perlova-Griff
        • Contact:
          • Gerd Graffunder, Dr.
        • Sub-Investigator:
          • Gerd Graffunder
      • Berlin, Germany, 12559
        • Recruiting
        • DRK Kliniken Berlin Köpenick Brustzentrum im Onkozentrum
        • Contact:
          • Anke Kleine-Tebbe, Dr.
        • Contact:
          • Kerstin Brandt, Dr.
        • Principal Investigator:
          • Anke Kleine-Tebbe
        • Sub-Investigator:
          • Kerstin Brandt
      • Bremen, Germany, 28209
        • Recruiting
        • Onkologisch-Hämatologische Schwerpunktpraxis
        • Contact:
          • Ralf Meyer, Dr. med.
        • Contact:
          • Carsten Schreiber, Dr. med.
        • Principal Investigator:
          • Ralf Meyer, Dr. med.
        • Sub-Investigator:
          • Carsten Schreiber, Dr. med.
      • Hamburg, Germany, 20259
        • Recruiting
        • AGAPLESION Diakonie-Klinikum Hamburg Gyn. Studienambulanz
        • Contact:
          • Mustafa Celalettin Ugur, Dr. med.
        • Contact:
          • Theresa Bernard, Dr. med.
        • Principal Investigator:
          • Mustafa Celalettin Ugur, Dr. med.
        • Sub-Investigator:
          • Theresa Bernard, Dr. med.
      • Hamburg, Germany, 20357
        • Recruiting
        • Mammazentrum Hamburg MVZ GbR
        • Principal Investigator:
          • Christian Schem, Prof. Dr.
        • Sub-Investigator:
          • Felix Hilpert, Prof. Dr.
        • Contact:
          • Christian Schem, Prof. Dr.
        • Contact:
          • Felix Hilpert, Prof. Dr.
      • Kassel, Germany, 34117
        • Recruiting
        • Brustzentrum, Elisabeth-Krankenhaus gGmbH
        • Contact:
          • Sabine Schmatloch, Dr.
        • Contact:
          • Daniel Borries, Dr.
        • Principal Investigator:
          • Sabine Schmatloch
        • Sub-Investigator:
          • Daniel Borries
      • Saarbrücken, Germany, 66113
        • Recruiting
        • Caritas Traegergesellschaft Saarbruecken mbH (CTS) Frauenklinik
        • Contact:
          • Mustafa Deryal, Dr
        • Contact:
          • Carolin Beckmann, Dr.
        • Principal Investigator:
          • Mustafa Deryal
        • Sub-Investigator:
          • Carolin Beckmann
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79110
        • Recruiting
        • Praxis für interdisziplinäre Onkologie & Hämatologie
        • Contact:
          • Matthias Zaiss, Dr. med.
        • Contact:
          • Norbert Marschner, Dr. med.
        • Principal Investigator:
          • Matthias Zaiss, Dr. med.
        • Sub-Investigator:
          • Norbert Marschner, Dr. med.
      • Heilbronn, Baden-Württemberg, Germany, 74078
        • Recruiting
        • SLK Kliniken Heilbronn Klinik für Gynäkologie und Geburtshilfe
        • Principal Investigator:
          • Beatrix Janke
        • Sub-Investigator:
          • Nadine Michel
        • Contact:
          • Beatrix Janke
        • Contact:
          • Nadine Michel
      • Ravensburg, Baden-Württemberg, Germany, 88212
        • Recruiting
        • Studienzentrum Onkologie Ravensburg Prof. Dr. Dechow, Prof. Dr. Decker, Dr. Nonnenbroich GbR
        • Contact:
          • Tobias Dechow, Prof. Dr.
        • Contact:
          • Thomas Decker, Prof. Dr.
        • Principal Investigator:
          • Thomas Decker, Prof. Dr.
        • Sub-Investigator:
          • Tobias Dechow, Prof. Dr.
      • Ulm, Baden-Württemberg, Germany, 89075
        • Recruiting
        • Universitätsklinikum Ulm Frauenheilkunde, Geburtshilfe
        • Contact:
          • Kristina Veselinovic, Dr. med.
        • Contact:
          • Fabienne Schochter, Dr. med.
        • Principal Investigator:
          • Kristina Veselinovic, Dr. med.
        • Sub-Investigator:
          • Fabienne Schochter, Dr. med.
      • Weinheim, Baden-Württemberg, Germany, 69469
        • Recruiting
        • GRN-Klinik Weinheim Gynäkologie und Geburtshilfe
        • Contact:
          • Lelia Bauer, Dr. med.
        • Contact:
          • Bettina Müller, Dr. med.
        • Principal Investigator:
          • Lelia Bauer, Dr. med.
        • Sub-Investigator:
          • Bettina Müller, Dr. med.
    • Baden-Wüttenburg
      • Tübingen, Baden-Wüttenburg, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen Department für Frauengesundheit, Brustzentrum
        • Contact:
          • Tobias Engler, Dr.
        • Contact:
          • Andreas Hartkopf, Prof.Dr.
        • Principal Investigator:
          • Andreas Hartkopf
        • Sub-Investigator:
          • Tobias Engler
    • Bavaria
      • Augsburg, Bavaria, Germany, 86150
        • Recruiting
        • Gemeinschaftspraxis Dr. Heinrich, Prof. Dr. Bangerter
        • Contact:
          • Bernhard Heinrich, Dr. med.
        • Contact:
          • Markus Bangerter, Prof. Dr.
        • Principal Investigator:
          • Bernhard Heinrich, Dr. med.
        • Sub-Investigator:
          • Markus Bangerter, Prof. Dr.
      • Munich, Bavaria, Germany, 80639
        • Recruiting
        • Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
        • Contact:
          • Christoph Salat, Prof. Dr.
        • Contact:
          • Oliver Stoetzer, PD. Dr.
        • Principal Investigator:
          • Christoph Salat, Prof. Dr.
        • Sub-Investigator:
          • Oliver Stoetzer, PD. Dr.
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Hämatologisch-Onkologische Schwerpunktpraxis Würzburg GbR Dr. Schöttker/ Dr. Pretscher
        • Contact:
          • Björn Schöttker, Dr. med.
        • Contact:
          • Dominik Pretscher, Dr. med.
        • Principal Investigator:
          • Dominik Pretscher, Dr. med.
        • Sub-Investigator:
          • Björn Schöttker, Dr. med.
    • Bayern
      • Muenchen, Bayern, Germany, 81377
        • Recruiting
        • Klinikum der Universität München Campus Großhadern Frauenheilunde und Geburtsklinik
        • Contact:
          • Nadia Harbeck, Prof. Dr.
        • Principal Investigator:
          • Nadia Harbeck, Prof. Dr.
        • Contact:
          • Rachel Würstlein
        • Sub-Investigator:
          • Rachel Würstlein, PD Dr. med.
      • München, Bayern, Germany, 80637
        • Recruiting
        • Rotkreuzkliniken München, Interdisziplinbäres Brustzentrum
        • Principal Investigator:
          • Michael Braun
        • Contact:
          • Michael Braun, Prof.Dr
        • Contact:
          • Claus Alexandra Hanusch, Dr
        • Sub-Investigator:
          • Claus Alexandra Hanusch
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • Recruiting
        • Carl-Thiem-Klinikum Cottbus Frauenklinik
        • Sub-Investigator:
          • Juliane Bock
        • Contact:
          • Nikola Bangemann, Dr. med.
        • Contact:
          • Juliane Bock
        • Principal Investigator:
          • Nikola Bangemann, Dr. med.
      • Potsdam, Brandenburg, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann gGmbH Brustzentrum
        • Principal Investigator:
          • Dorothea Fischer
        • Contact:
          • Dorothea Fischer, Prof.Dr.
        • Contact:
          • Björn Beurer, Dr.
        • Sub-Investigator:
          • Björn Beurer
    • Hesse
      • Frankfurt a.M., Hesse, Germany, 60389
        • Recruiting
        • Onco Medical Consult GmbH
        • Contact:
          • Hans Tesch, Prof. Dr.
        • Contact:
          • Jochen Breuer, Dr. med.
        • Principal Investigator:
          • Hans Tesch, Prof. Dr.
        • Sub-Investigator:
          • Jochen Breuer, Dr. med.
      • Langen, Hesse, Germany, 63225
        • Recruiting
        • Gemeinschaftspraxis für Hämatologie und Onkologie
        • Contact:
          • Andreas Köhler, Dr. med.
        • Contact:
          • Roswitha Fuchs, Dr. med.
        • Principal Investigator:
          • Andreas Köhler, Dr. med.
        • Sub-Investigator:
          • Roswitha Fuchs, Dr. med.
    • Hessen
      • Wiesbaden, Hessen, Germany, 65189
        • Recruiting
        • St. Josefs-Hospital Wiesbaden GmbH Ambulanz der Frauenklinik, Brustzentrum
        • Contact:
          • Antje Lehnert, Dr
        • Contact:
          • Anna-Kathrin Bicker, Dr
        • Principal Investigator:
          • Antje Lehnert
        • Sub-Investigator:
          • Anna-Kathrin Bicker
    • Lower Saxony
      • Braunschweig, Lower Saxony, Germany, 38100
        • Recruiting
        • Studien GbR Braunschweig Dr. Lorenz/Dr. Kreiss-Sender
        • Contact:
          • Janine Kreiss-Sender, Dr. med.
        • Contact:
          • Ralf Lorenz, Dr. med.
        • Principal Investigator:
          • Janine Kreiss-Sender, Dr. med.
        • Sub-Investigator:
          • Ralf Lorenz, Dr. med.
      • Goslar, Lower Saxony, Germany, 38642
        • Recruiting
        • ÜBAG MVZ Onkologische Kooperation Harz
        • Contact:
          • Mark-Oliver Zahn, Dr. med.
        • Contact:
          • Timo Kambach, Dr. med.
        • Principal Investigator:
          • Mark-Oliver Zahn, Dr. med.
        • Sub-Investigator:
          • Timo Kambach, Dr. med.
      • Hannover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover Frauenheilkunde
        • Principal Investigator:
          • Tjoung-Won Park-Simon, Prof. Dr.
        • Contact:
          • Tjoung-Won Park-Simon, Prof. Dr.
        • Contact:
          • Elna Kühnle, Dr. med.
        • Sub-Investigator:
          • Elna Kühnle, Dr. med.
      • Leer, Lower Saxony, Germany, 26789
        • Recruiting
        • Onkologie UnterEms Leer-Emden-Papenburg Dr. L. Müller
        • Contact:
          • Lothar Müller, Dr. med.
        • Contact:
          • Detlev Schröder, Dr. med.
        • Principal Investigator:
          • Lothar Müller, Dr. med.
        • Sub-Investigator:
          • Detlev Schröder, Dr. med.
      • Oldenburg, Lower Saxony, Germany, 26121
        • Recruiting
        • Pius-Hospital Oldenburg Hämatologie, Onkologie
        • Contact:
          • Frank Griesinger, Prof. Dr.
        • Principal Investigator:
          • Frank Griesinger, Prof. Dr.
        • Contact:
          • Anne Lüers, Dr. med.
        • Sub-Investigator:
          • Anne Lüers, Dr. med.
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • Recruiting
        • Klinikum Südstadt Rostock Frauenklinik
        • Principal Investigator:
          • Toralf Reimer, Prof. Dr.
        • Contact:
          • Toralf Reimer, Prof. Dr.
        • Contact:
          • Christian George, Dr. med.
        • Sub-Investigator:
          • Christian George, Dr. med.
    • NRW
      • Aachen, NRW, Germany, 52074
        • Recruiting
        • Uniklinik RWTH Aachen Gynäkologie und Geburtsmedizin
        • Contact:
          • Elmar Stickeler, Prof. Dr.
        • Contact:
          • Katja Krauss, Dr. med.
        • Principal Investigator:
          • Katja Krauss, Dr. med.
        • Sub-Investigator:
          • Elmar Stickeler, Prof. Dr.
      • Aachen, NRW, Germany, 52066
        • Recruiting
        • Marienhospital GmbH Studienzentrale Brustcentrum Aachen-Kreis Heinsberg
        • Contact:
          • Mahmoud Danaei, Dr
        • Contact:
          • Miriam Kohlschein
        • Principal Investigator:
          • Mahmoud Danaei
        • Sub-Investigator:
          • Miriam Kohlschein
      • Bergisch Gladbach, NRW, Germany, 51465
        • Recruiting
        • Evangelisches Krankenhaus Bergisch Gladbach gGmbH Brustzentrum,
        • Contact:
          • Lena Leitzen
        • Contact:
          • Christian Rudlowski, Prof.Dr.
        • Principal Investigator:
          • Christian Rudlowski
        • Sub-Investigator:
          • Lena Leitzen
      • Bielefeld, NRW, Germany, 33604
        • Recruiting
        • Onkologische Schwerpunktpraxis Bielefeld
        • Contact:
          • Marianne Just, Dr. med.
        • Contact:
          • Siemke Steinke, Dr. med.
        • Principal Investigator:
          • Marianne Just, Dr. med.
        • Sub-Investigator:
          • Siemke Steinke, Dr. med.
      • Bonn, NRW, Germany, 53111
        • Recruiting
        • Gynäkologisches Zentrum Bonn PD Dr. med. Christian Kurbacher
        • Sub-Investigator:
          • Jutta Kurbacher
        • Contact:
          • Christian Martin Kurbacher, PD. Dr.
        • Contact:
          • Jutta Kurbacher
        • Principal Investigator:
          • Christian Martin Kurbacher, Prof. Dr.
      • Cologne, NRW, Germany, 50679
        • Recruiting
        • GYNONOVA GbR Schwerpunktpraxis für gynäkologische Onkologie
        • Contact:
          • Katja Ziegler-Löhr, Dr. med.
        • Contact:
          • Solvejg Rellecke, Dr. med.
        • Principal Investigator:
          • Katja Ziegler-Löhr, Dr. med.
        • Sub-Investigator:
          • Solvejg Rellecke, Dr. med.
      • Düsseldorf, NRW, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf Frauenheilkunde und 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 Brustzentrum
        • Contact:
          • Maren Darsow, Dr. med.
        • Contact:
          • Athina Kostara, Dr. med.
        • Principal Investigator:
          • Maren Darsow, Dr. med.
        • Sub-Investigator:
          • Athina Kostara, Dr. med.
      • Eschweiler, NRW, Germany, 52249
        • Recruiting
        • St.-Antonius-Hospital Eschweiler Hämatologie/Onkologie
        • Contact:
          • Peter Staib, PD. Dr.
        • Contact:
          • Meike Münchow, Dr. med.
        • Principal Investigator:
          • Peter Staib, PD. Dr.
        • Sub-Investigator:
          • Meike Münchow, Dr. med.
      • Essen, NRW, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum
        • Contact:
          • Mattea Reinisch, Dr. med.
        • Contact:
          • Sherko Kümmel, Prof. Dr.
        • Principal Investigator:
          • Mattea Reinisch, Dr. med.
        • Sub-Investigator:
          • Sherko Kümmel, Prof. Dr.
      • Essen, NRW, Germany, 45147
        • Recruiting
        • Universitätsklinikum Essen Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Oliver Hoffmann, PD. Dr.
        • Contact:
          • Oliver Hoffmann, PD. Dr.
        • Contact:
          • Ann-Kathrin Bittner, PD. Dr.
        • Sub-Investigator:
          • Ann-Kathrin Bittner, PD. Dr.
      • Gütersloh, NRW, Germany, 33332
        • Recruiting
        • Onkologische Schwerpunktpraxis
        • Contact:
          • Reinhard Depenbusch, Dr. med.
        • Contact:
          • Philipp Schütt, PD Dr.
        • Principal Investigator:
          • Reinhard Depenbusch, Dr. med.
        • Sub-Investigator:
          • Philipp Schütt, PD Dr.
      • Hildesheim, NRW, Germany, 31134
        • Recruiting
        • Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative Gynäkologie
        • Contact:
          • Christoph Uleer, Dr. med.
        • Contact:
          • Jasmin Pourfard, Dr. med.
        • Principal Investigator:
          • Christoph Uleer, Dr. med.
        • Sub-Investigator:
          • Jasmin Pourfard, Dr. med.
      • Krefeld, NRW, Germany, 47805
        • Recruiting
        • Zentrum für ambulante gynäkologisch Onkologie - ZAGO Haus 03
        • Contact:
          • Gunther Rogmans, Dr. med.
        • Contact:
          • Marina Wirtz, Dr. med.
        • Principal Investigator:
          • Gunther Rogmans, Dr. med.
        • Sub-Investigator:
          • Marina Wirtz, Dr. med.
      • Köln, NRW, Germany, 50935
        • Recruiting
        • St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie
        • Contact:
          • Julian Puppe, Dr.
        • Principal Investigator:
          • Julian Puppe
        • Contact:
          • Anne-Katrin Oligmüller, Dr.
        • Sub-Investigator:
          • Anne-Katrin Oligmüller
      • Lüneburg, NRW, Germany, 21339
        • Recruiting
        • Städtisches Klinikum Lüneburg Frauenklinik
        • Contact:
          • Peter Dall, Prof. Dr.
        • Contact:
          • Eric Boetel, Dr. med.
        • Principal Investigator:
          • Peter Dall
        • Sub-Investigator:
          • Eric Boetel
      • Minden, NRW, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden Innere Medizin, Hämatologie, Onkologie
        • Contact:
          • Martin Griesshammer, Prof. Dr.
        • Contact:
          • Hans-Joachim Tischler, Dr. med.
        • Principal Investigator:
          • Martin Griesshammer, Prof. Dr.
        • Sub-Investigator:
          • Hans-Joachim Tischler, Dr. med.
      • Moenchengladbach, NRW, Germany, 41061
        • Recruiting
        • Brustzentrum Niederrhein, im ev. Krankenhaus Bethesda
        • Contact:
          • Oleg Gluz, PD. Dr. med.
        • Contact:
          • Raquel von Schumann
        • Principal Investigator:
          • Oleg Gluz, PD Dr. med.
        • Sub-Investigator:
          • Raquel von Schumann
      • Münster, NRW, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster Brustzentrum
        • Contact:
          • Joke Tio, Dr. med.
        • Contact:
          • Carl Christian Opitz, Dr. med.
        • Principal Investigator:
          • Joke Tio, Dr. med.
        • Sub-Investigator:
          • Carl Christian Opitz, Dr. med.
      • Schwerte, NRW, Germany, 58239
        • Recruiting
        • Marien Krankenhaus Schwerte MKS St. Paulus GmbH
        • Contact:
          • Sarah Wetzig
        • Contact:
          • Michael Hartmann, Dr.
        • Principal Investigator:
          • Sarah Wetzig
        • Sub-Investigator:
          • Michael Hartmann
      • Unna, NRW, Germany, 59423
        • Recruiting
        • Christliches Klinikum Unna Mitte Gynäkologie und Geburtshilfe
        • Contact:
          • Cristin Kühn, Dr. med.
        • Contact:
          • Heidi Wortelmann, Dr. med.
        • Principal Investigator:
          • Cristin Kühn, Dr. med.
        • Sub-Investigator:
          • Heidi Wortelmann, Dr. med.
      • Witten, NRW, Germany, 58452
        • Recruiting
        • Marien Hospital Witten Brustzentrum
        • Sub-Investigator:
          • Matthias Zeth
        • Contact:
          • John Hackmann, Dr. med.
        • Contact:
          • Matthias Zeth
        • Principal Investigator:
          • John Hackmann, Dr. med.
      • Wuppertal, NRW, Germany, 42283
        • Recruiting
        • Helios Klinikum Wuppertal Landesfrauenklinik
        • Contact:
          • Vesna Bjelic-Radisic, Prof. Dr.
        • Principal Investigator:
          • Vesna Bjelic-Radisic, Prof. Dr.
    • Niedersachsen
      • Georgsmarienhütte, Niedersachsen, Germany, 49124
        • Recruiting
        • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie
        • Contact:
          • Kerstin Lüdtke-Heckenkamp, Dr. med.
        • Contact:
          • Jost Christoph Wamhoff, Dr. med.
        • Principal Investigator:
          • Kerstin Lüdtke-Heckenkamp, Dr. med.
        • Sub-Investigator:
          • Jost Christoph Wamhoff, Dr. med.
      • Hannover, Niedersachsen, Germany, 30559
        • Recruiting
        • Diakovere Henriettenstift Frauenklinik
        • Contact:
          • Kristina Lübbe, Dr. med.
        • Contact:
          • Angela Kentsch, Dr. med.
        • Principal Investigator:
          • Kristina Lübbe, Dr. med.
        • Sub-Investigator:
          • Angela Kentsch, Dr. med.
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51067
        • Recruiting
        • Kliniken der Stadt Köln Krankenhaus Köln-Holweide Medizinische Klinik Brustzentrum
        • Contact:
          • Mathias Warm, MD
        • Contact:
          • Myriam Vincent
        • Principal Investigator:
          • Mathias Warm, Prof. Dr.
        • Sub-Investigator:
          • Myriam Vincent, Dr. med.
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany, 54290
        • Recruiting
        • Klinikum Mutterhaus der Borromäerinnen Innere Medizin 1
        • Contact:
          • Rolf Mahlberg, Dr. med.
        • Contact:
          • Stefan Heidel, Dr. med.
        • Principal Investigator:
          • Rolf Mahlberg, Dr. med.
        • Sub-Investigator:
          • Stefan Heidel, Dr. med.
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56068
        • Recruiting
        • Praxisklinik für Hämatologie und Onkologie Koblenz
        • Contact:
          • Rudolf Weide, Prof. Dr.
        • Principal Investigator:
          • Rudolf Weide, Prof. Dr.
        • Contact:
          • Jörg Thomalla, Dr. med.
        • Sub-Investigator:
          • Jörg Thomalla, Dr. med.
    • Saarland
      • Homburg (Saar), Saarland, Germany, 66421
        • Recruiting
        • Universitätsklinikum des Saarlandes Klinik für Frauenheilkunde
        • Principal Investigator:
          • Erich-Franz Solomayer, Prof. Dr.
        • Contact:
          • Erich-Franz Solomayer, Prof. Dr.
        • Contact:
          • Lisa Stotz, Dr. med.
        • Sub-Investigator:
          • Lisa Stotz, Dr. med.
    • Sachsen
      • Rodewisch, Sachsen, Germany, 8228
        • Recruiting
        • Klinikum Obergöltzsch Brustzentrum Vogtland
        • Contact:
          • Stefanie Strobel, Dr.
        • Contact:
          • Barbara Prediger, Dr
        • Principal Investigator:
          • Stefanie Strobel
        • Sub-Investigator:
          • Barbara Prediger
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz Frauenheilkunde und Geburtshilfe
        • Sub-Investigator:
          • Franziska Stuckert
        • Contact:
          • Petra Krabisch, Dr. med.
        • Contact:
          • Franziska Stuckert
        • Principal Investigator:
          • Petra Krabisch, Dr. med.
      • Dresden, Saxony, Germany, 01127
        • Recruiting
        • Onkozentrum Dresden/Freiberg
        • Contact:
          • Thomas Göhler, Dr. med.
        • Contact:
          • Steffen Dörfel, Dipl.-Med.
        • Principal Investigator:
          • Thomas Göhler, Dr. med.
        • Sub-Investigator:
          • Steffen Dörfel, Dipl.-Med.
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Onkologische Gemeinschaftspraxis
        • Contact:
          • Gabriele Prange-Krex, Dr. med.
        • Contact:
          • Johannes Mohm, Dr. med.
        • Principal Investigator:
          • Gabriele Prange-Krex, Dr. med.
        • Sub-Investigator:
          • Johannes Mohm, Dr. med.
      • Leipzig, Saxony, Germany, 04129
        • Recruiting
        • Klinikum St. Georg Gynäkologie und Geburtshilfe
        • Principal Investigator:
          • Uwe Köhler, Prof. Dr.
        • Contact:
          • Uwe Köhler, Prof. Dr.
        • Contact:
          • Catrin Frömter, Dr. med.
        • Sub-Investigator:
          • Catrin Frömter, Dr. med.
    • Saxony Anhalt
      • Halle (Saale), Saxony Anhalt, Germany, 06120
        • Recruiting
        • Universitätsklinikum Halle (UKH), Universitätsklinik und Poliklinik für Gynäkologie
        • Principal Investigator:
          • Christoph Thomssen, Prof. Dr.
        • Contact:
          • Christoph Thomssen, Prof. Dr.
        • Contact:
          • Susanne Barrot, Dr. med.
        • Sub-Investigator:
          • Susanne Barrot, Dr. med.
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39130
        • Recruiting
        • Klinikum Magdeburg Frauenheilkunde und Geburtshilfe
        • Contact:
          • Holm Eggemann, Prof. Dr.
        • Contact:
          • Daniela Meiners
        • Principal Investigator:
          • Holm Eggemann, Prof. Dr.
        • Sub-Investigator:
          • Daniela Meiners
      • Stendal, Saxony-Anhalt, Germany, 39576
        • Recruiting
        • Johanniter Krankenhaus Frauenklinik
        • Contact:
          • Andrea Stefek, Dr. med.
        • Contact:
          • Sylvia Ruth, Dr. med.
        • Principal Investigator:
          • Andrea Stefek, Dr. med.
        • Sub-Investigator:
          • Sylvia Ruth, Dr. med.

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:

A. Prior to REGISTRATION

1. Written informed consent prior to any study procedures (outcomes of standard-of-care procedures performed before signing of informed consent by the patient but within allowed screening period can be used for screening of patient). 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of initiation of 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, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range.

    4b. OR: Pre-/perimenopausal patients:

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

  • patient has had a hysterectomy. 5. Histologically confirmed diagnosis(by local laboratory ) of estrogen-receptor positive and/or progesterone-receptor positive (>1% ) primary early breast cancer or local relapse. In case the receptor status from local pathology is unclear a central pathology review is obligatory. Results must be known prior to randomization.

    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 analyzed tissue sample at initial diagnosis by a local laboratory).

    7. Patients are eligible

  • with completed (i.e., 5 years according to SoC), planned or ongoing adjuvant endocrine therapy, without any signs of distant relapse or secondary malignancy AND
  • if primary diagnosis was 6 years or less before enrollment 8a. Intermediate to high clinical or genomic risk, defined as either one of the following criteria:
  • c or p or ypN 2-3 with/without (neo)adjuvant chemotherapy;
  • in patients with c/ypN0-1:
  • non-pCR in patients with G3 or c/ypN1
  • high biological risk defined as G3 with Ki-67 ≥40%
  • or high genomic risk (RS>25 (known or Oncotype Dx® in screening phase) or another test)
  • high CTS5 score or UICC stage IIb (clinical if neoadjuvant chemotherapy or pathological)

OR, if patients do not fulfill above criteria:

  • patients ≤50 years old or pre-/perimenopausal and c or (y)pN1 disease (in particular if ET-non-response or no chemotherapy)
  • patients >50 years old and postmenopausal and c or (y)pN1 with intermediate genomic risk (RS≥18) or non-low risk by another test

ET non-response definition:

Ki-67 post-treatment > 10% (central or local pathology value) OR 8b. Patients after isolated locoregional relapse with high-risk patterns (e.g., rpT2-3 or rpN1-3 or G3 or Ki-67 pre-treatment ≥20%), once surgery with free margins was completed Note: Inclusion is only possible for the first locoregional relapse removed by surgery (free margins) OR 8c. Patients with any high clinical risk at Investigator´s assessment but not fulfilling above criteria: consultation with sponsor required

B. Prior to RANDOMIZATION in the study 9. Completed primary therapy of breast cancer according to current guidelines, i.e., after (neo)adjuvant treatment, definite surgery and radiotherapy, if applicable.

10. No clinical evidence of distant metastasis (confirmation recommended prior to randomization by either combination of or either one of the following examinations: CT thorax / abdomen, chest X-ray, liver ultrasound, bone scan, PET-CT). 11. Patient has available tumor tissue from primary diagnostic biopsy. 12. No contraindication for adjuvant ET. 13. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 14. 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 ≥ 8.0 g/dL,
  • total bilirubin ≤ 1.5 ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 2.0 × ULN or direct bilirubin within normal ranges,
  • aspartate transaminase (AST) ≤ 3 × ULN,
  • alanine transaminase (ALT) ≤ 3 × ULN,

  • serum creatinine ≤ 1.5 x ULN. 15. Ability to swallow abemaciclib tablets or to administer other study medication, respectively.

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

    17. Willing to receive therapy by 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. Previously received CDK 4/6 inhibitor.
  3. Patient with a known hypersensitivity to any of the excipients of abemaciclib or standard-of-care endocrine therapy.
  4. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  5. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1 (polyneuropathy ≤ 2 is allowed).
  6. Patient has a concurrent malignancy or non-breast malignancy within 5 years prior to randomization.
  7. 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).
  8. Patient has any active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
  9. 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., interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, etc.).
  10. Patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.

  11. Patient is currently receiving any of the following substances, which cannot be discontinued 7 days prior to day 1 of study treatment:

    o concomitant medications and herbal supplements, that are strong inducers or inhibitors of CYP3A4.

  12. Participation in a prior investigational study within 30 days prior to enrollment.
  13. Not able to understand and to comply with study instructions and requirements.
  14. Pregnant or nursing (lactating) woman.

  15. 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:

    1. total abstinence (when this is in line with the preferred and usual lifestyle of the patient).
    2. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment.
    3. 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.
    4. placement of an intrauterine device (IUD).
    5. use of condom + spermicide.
  16. 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: Abemaciclib plus ET
Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice
Drug: Abemaciclib 50 MG; 150mg 1-0-1 per os
Experimental: Abemaciclib plus ET Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice
Other Names:
  • Verzenios
No Intervention: Standard-of-care ET

Standard-of-care ET according to clinical guidelines.

Pre-/perimenopausal patients:

  • Either aromatase inhibitor + GnRH agonist
  • or Tamoxifen +/- GnRH-agonist (as per investigator´s decision) or

Postmenopausal patients:

  • Either Aromatase inhibitor
  • or Tamoxifen OR

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, 3-6 years after start of study treatment
superiority in invasive disease-free survival (iDFS) of abemaciclib + endocrine therapy vs. standard-of-care endocrine therapy in patients with HR+/HER2- high risk breast cancer.
at end of study, 3-6 years after start of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: at end of study, 3-6 years after start of treatment
assessment of overall survival (OS) and distant DFS (dDFS) in both arms
at end of study, 3-6 years after start of treatment
differences in overall survival (OS) and dDFS
Time Frame: at end of study, 3-6 years after start of study treatment
differences in overall survival (OS) and dDFS between arms
at end of study, 3-6 years after start of study treatment
subgroup and multivariable survival analyses
Time Frame: at end of study, 3-6 years after start of study treatment
subgroup and multivariable survival analyses
at end of study, 3-6 years after start of study treatment
CNS metastases
Time Frame: at end of study, 3-6 years after start of study treatment
occurrence of CNS metastases
at end of study, 3-6 years after start of study treatment
EORTC QLQ-C30
Time Frame: at end of study, on average 3-6 years after start of treatment
quality of life (QoL)
at end of study, on average 3-6 years after start of treatment
EORTC QLQ-BR23
Time Frame: at end of study, on average 3-6 years after start of treatment
quality of life (QoL)
at end of study, on average 3-6 years after start of treatment
EQ-5D-5L
Time Frame: at end of study, on average 3-6 years after start of treatment
quality of life (QoL)
at end of study, on average 3-6 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

Eli Lilly and Company
Genomic Health®, Inc.

Investigators

  • Principal Investigator: Oleg Gluz, PD Dr. med., Westdeutsche Studiengruppe GmbH

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)

September 2, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSG-AM11
  • 2019-001488-60 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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