Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The MINERVA Trial aims to evaluate safety, efficacy and quality of life (QoL) for the combination of Abemaciclib with an Aromatase Inhibitor or Fulvestrant in pre- and postmenopausal patients with metastatic hormone receptor positive HER2 negative breast cancer in the first line setting. Side effect monitoring and patient reported outcomes will be captured using the web- and app-based CANKADO digital health application. Via this user-friendly tool the patients can document their therapy side effects (e.g. diarrhea) and outcomes on a day-to-day basis. The capturing of side effects using the digital health application will be done additionally to the regular AE documentation. Furthermore, translational research objectives of this trial include the investigation of biomarkers (ct-DNA, germline DNA) to evaluate whether they can give insights into the reasons for response, intrinsic or acquired resistance to the combined endocrine

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobieta w wieku co najmniej 18 lat
  • Podpisana świadoma zgoda na udział w badaniu
  • Rak piersi z receptorami hormonalnymi dodatnimi (HR+) i bez nadekspresji HER2
  • Zaawansowana choroba miejscowo nawrotowa lub przerzuty, które nie można operować lub leczyć promieniowaniem
  • Wskazanie do leczenia endokrynologicznego
  • Ogólny stan zdrowia nie gorszy niż 2 w skali ECOG
  • Przerzuty do mózgu (jeśli obecne) muszą być ustabilizowane
  • Gotowość do uczestniczenia przez całą długość badania i przestrzegania procedur

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
May 16, 2025
Sex
Female only

Therapies / drugs in trial

Locations (54)

Kliniken Ostalb gkAöR

Aalen, Germany

Klinikum St. Marien Kommunalunternehmen - AöR Der Stadt Amberg

Amberg, Germany

Klinikum Aschaffenburg-Alzenau gGmbH

Aschaffenburg, Germany

Gemeinschaftspraxis Dr. Heinrich / Dr. Bangerter

Augsburg, Germany

Universitätsklinikum Augsburg A.d.ö.R

Augsburg, Germany

MediOnko-Institut GbR

Berlin, Germany

Hämatologikum Biberach

Biberach, Germany

Gynäkologisches Zentrum Bonn - Friedensplatz

Bonn, Germany

Studien GbR Braunschweig

Braunschweig, Germany

Hämato-Onkologische Praxis im Medicum

Bremen, Germany

St. Elisabeth-Krankenhaus GmbH

Cologne, Germany

Onkologisches Zentrum Donauwörth

Donauwörth, Germany

Gemeinschaftspraxis

Dresden, Germany

Onkozentrum Dresden

Dresden, Germany

MVZ Medical Center Düsseldorf GmbH

Düsseldorf, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Internistische Praxis Ehingen

Ehingen, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

St. Antonius-Hospital

Eschweiler, Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Krankenhäuser Landkreis Freudenstadt gGmbH

Freudenstadt, Germany

Internistische Gemeinschaftspraxis

Friedrichshafen, Germany

Klinikum Garmisch-Partenkirchen GmbH

Garmisch-Partenkirchen, Germany

Main-Kinzig-Kliniken gGmbH Gelnhausen

Gelnhausen, Germany

Gemeinschaftspraxis und Tagesklinik Halle

Halle, Germany

Albertinen-Krankenhaus

Hamburg, Germany

Sana Klinikum Hameln-Pyrmont

Hamelin, Germany

Frauenärzte am Bahnhofsplatz

Hildesheim, Germany

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Germany

Klinikum Kassel GmbH

Kassel, Germany

Klinikverbund Kempten-Oberallgäu gGmbH

Kempten, Germany

Klinikum Konstanz

Konstanz, Germany

ZAGO- Zentrum für ambulante gynäkologische Onkologie

Krefeld, Germany

Krankenhausgesellschaft St. Vincenz mbH

Limburg, Germany

Praxis für gynäkologische Onkologie / Prof. Dr. med. Ulrike Nitz / Raquel von Schumann

Mönchengladbach, Germany

Kliniken Ostalb gkAöR, Stauferklinikum Schwäbisch Gmünd

Mutlangen, Germany

LMU - Klinikum der Universität München

München, Germany

München Klinik gGmbH Harlaching

München, Germany

TZN-Tumorzentrum Niederrhein GmbH

Neuss, Germany

Klinikum Nürnberg Nord

Nuremberg, Germany

medius KLINIK NÜRTINGEN

Nürtingen, Germany

Praxis Dr. Guth

Plauen, Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, Germany

Klinikum Rheine

Rheine, Germany

GPR Gesundheits- und Pflegezentrum Rüsselsheim gGmbH

Rüsselsheim am Main, Germany

Diakoneo Diak-Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, Germany

Clinical Research Stolberg GmbH

Stolberg, Germany

Gynäkologie Kompetenzzentrum Stralsund

Stralsund, Germany

Universitätsfrauenklinik Tübingen

Tübingen, Germany

University Hospital Ulm Gynecology/Obstetrics

Ulm, Germany

St. Josefs-Hospital

Wiesbaden, Germany

Spital Wallis

Brig, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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