RecruitingPhase 4NCT05362760

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

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. The MINERVA Trial - A Phase IV Trial

Sponsor

Prof. Wolfgang Janni

Enrollment

300 participants

Start Date

Apr 27, 2022

Study Type

INTERVENTIONAL

Conditions

Hormone Receptor-positive Metastatic Breast Cancer HER2-negative Metastatic Breast Cancer

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how an oral drug called abemaciclib, combined with hormone therapy, works in women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer — with a special focus on using a digital app to manage and track side effects. **You may be eligible if...** - You are a woman aged 18 or older - You have hormone receptor-positive (HR+), HER2-negative breast cancer that is locally advanced or has spread to other parts of the body - Your doctor has prescribed or is considering abemaciclib combined with hormone therapy as part of your standard care - You are willing to use a digital tool to report side effects and follow study procedures **You may NOT be eligible if...** - You have a different breast cancer subtype (e.g., HER2-positive or triple-negative) - You are unable to provide informed consent - You have serious health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib + Aromatase Inhibitor

Abemaciclib 150 mg orally every 12 hours plus Aromatase Inhibitor ( Anastrozole 1 mg, Letrozole 2.5 mg or exemestane 25 mg orally every 24 hours on Days 1 to 28 of a 28-day cycle)

DRUGAbemaciclib + Fulvestrant

Abemaciclib 150 mg orally every 12 hours plus Fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on Day 1 of a 28-day cycle)

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

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NCT05362760