RecruitingPhase 4NCT05452213

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients


Sponsor

Institut fuer Frauengesundheit

Enrollment

1,000 participants

Start Date

Oct 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study analyzes tissue samples from breast cancer patients treated with a drug called ribociclib (a CDK4/6 inhibitor, which slows cancer cell division) to understand why some tumors respond and others develop resistance over time. It is an observational study focused on molecular analysis, not a new treatment trial. **You may be eligible if...** - You have been diagnosed with HR-positive, HER2-negative breast cancer - You have received or are receiving ribociclib as part of your treatment - You are willing to provide tumor tissue samples (biopsy) - You are 18 or older **You may NOT be eligible if...** - You are unable to undergo tumor biopsy safely - You have not received ribociclib as part of your cancer treatment - You are unwilling to provide tissue samples 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

DRUGRibociclib

All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard. Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day. Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.


Locations(52)

Department of Gynecology and Obstetrics, Erlangen University Hospital

Erlangen, Bavaria, Germany

Department of Gynecology and Obstetrics, University Medicine Mainz

Mainz, Hesse, Germany

Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, Germany

Klinikum St Marien Amberg

Amberg, Germany

Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

Aschaffenburg, Germany

Klinik für Hämatologie und Onkologie, Uniklinik Augsburg

Augsburg, Germany

University Hospital Augsburg

Augsburg, Germany

Frauenklinik des Klinikums Bamberg

Bamberg, Germany

MediOnko GbR

Berlin, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik

Bonn, Germany

Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte

Bremen, Germany

Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe

Chemnitz, Germany

Kliniken Der Stadt Köln gGmbH

Cologne, Germany

Carl-Thiem-Klinikum Cottbus

Cottbus, Germany

Staedtisches Klinikum Dessau, Gynecology and Obstetrics

Dessau, Germany

Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden

Dresden, Germany

Universitaetsklinikum Duesseldorf AöR

Düsseldorf, Germany

Universitaetsklinikum Essen AöR, Gynecology and Obstetrics

Essen, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics

Frankfurt am Main, Germany

Universitäts-Frauenklinik Frankfurt

Frankfurt am Main, Germany

Universitäts-Frauenklinik Freiburg

Freiburg im Breisgau, Germany

Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche

Georgsmarienhütte, Germany

Universitäts-Frauenklinik Hamburg-Eppendorf

Hamburg, Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, Germany

Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe

Heidelberg, Germany

Frauenklinik, SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics

Karlsruhe, Germany

University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics

Kiel, Germany

ZAGO-Zentrum für ambulante gynäkologische Onkologie

Krefeld, Germany

Klinikum Kulmbach

Kulmbach, Germany

VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf

Landshut, Germany

Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms

Leer, Germany

Universitäts-Frauenklinik Leipzig

Leipzig, Germany

Ev. Krankenhaus Bethesda Mönchengladbach

Mönchengladbach, Germany

Hämatologie Onkologie Gemeinschaftspraxis Pasing

Munich, Germany

MVZ Nordhausen gGmbH

Nordhausen, Germany

Klinikum Nürnberg

Nuremberg, Germany

Frauenklinik, Medius Klinik Nürtingen

Nürtingen, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Ravensburg, Germany

Frauenklinik, Diakoniekrankenhaus Rotenburg

Rotenburg (Wümme), Germany

Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH

Schweinfurt, Germany

Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik

Singen, Germany

Onkologische Schwerpunktpraxis Speyer

Speyer, Germany

Klinikum Stuttgart

Stuttgart, Germany

Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie

Troisdorf, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Universitäts-Frauenklinik Ulm

Ulm, Germany

MVZ Nordoberpfalz

Weiden, Germany

Medizinische Studiengesellschaft Nord-West GmbH

Westerstede, Germany

Rems-Murr Kliniken Winnenden

Winnenden, Germany

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NCT05452213


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