Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Recruiting · NCT05452213 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut fuer Frauengesundheit
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with cycline dependent kinase 4/6 (CDK4/6) inhibitors is allowed in the adjuvant setting)
- Written informed consent prior to beginning of trial specific procedures
- Subject must be female and aged ≥ 18 years on the day of signing informed consent
- Locally advanced or metastatic breast cancer not amenable to curative treatment
- Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory
- Histologically confirmed estrogen receptor (ER) positive and/ or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.
- corrected QT (QTcF) interval \< 450 ms
- Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
- Women of childbearing potential must have a negative urine or serum pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the trial through 21 days after the last dose of trial treatment.
- Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
Exclusion criteria
- Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer
- Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
- Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
- Patients who are pregnant or lactating.
- Patients with existing or patients who are at significant risk of developing corrected QT interval (QTc) prolongation. This includes
- patients with long QT syndrome
- uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia
- electrolyte abnormalities
- Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.
- Patients with active systemic infections (for example, bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection requiring systemic therapy) or viral load (such as known human immunodeficiency virus positivity or with known active hepatitis B or C, for example, hepatitis B surface antigen positive).
- Patients with serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, 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 clinically significant diarrhea).
- Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)
Where it is running
52 locations listed.
- 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
- Hämatologie Onkologie Gemeinschaftspraxis Pasing - Munich, Germany
- Ev. Krankenhaus Bethesda Mönchengladbach - Mönchengladbach, 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
- 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