Tests ribociclib in people with advanced hormone-positive breast cancer
Tests ribociclib in adults with advanced HER2-negative, hormone-positive breast cancer.
Plain-language title generated from the registry record
Registry title: CAPTOR-BC: COMPREHENSIVE ANALYSIS OF SPATIAL, TEMPORAL AND MOLECULAR PATTERNS OF RIBOCICLIB EFFICACY AND RESISTANCE IN ADVANCED BREAST CANCER PATIENTS
Key facts
- Where
- Amberg, Aschaffenburg, Augsburg, Bad Nauheim, Bamberg, Bergisch Gladbach, Berlin, Bottrop, Bremen, Celle, Chemnitz, Cologne, Cottbus, Dessau-Rosslau, Dresden, Duesseldorf, Eggenfelden, Elxleben, Erlangen, Essen, Esslingen am Neckar, Eutin, Frankfurt am Main, Frankfurt Am Main, Freiburg im Breisgau, Fürstenwalde, Fürth, Georgsmarienhuette, Gifhorn, Goettingen, Göttingen, Gummersbach, Günzburg, Halle, Hamburg, Hamm, Hanau, Hanover, Heidelberg, Heilbronn, Homburg, Ilsede, Karlsruhe, Kempten (Allgau), Kiel, Krefeld, Kulmbach, Landshut, Langen (Hessen), Lebach, Leipzig, Lemgo, Lörrach, Magdeburg, Mainz, Marburg, Marktredwitz, Mayen, Minden, Mönchengladbach, Munich, Münster, Neumarkt, Nordhausen, Nuertingen, Nuremberg, Paderborn, Plauen, Potsdam, Ravensburg, Regensburg, Rheine, Rosenheim, Rotenburg (wümme), Ruesselsheim Am Main, Salzwedel, Hansestadt, Scheuditz, Schorndorf, Schweinfurt, Singen (hohentwiel), Soest, Speyer, Stendal, Stralsund, Stuttgart, Torgau, Trier, Troisdorf, Tuebingen, Ulm, Waldkirchen, Weiden I.D.Opf., Weinheim, Wesel, Westerstede, Wiesbaden, Winnenden, Wolfenbüttel, and Wuppertal, GermanySee the 123 sites
- Phase
- Phase 4
Where in Germany
- Klinikum St. Marien AmbergAmberg, GermanyTaking people
- Klinikum Aschaffenburg-Alzenau gGmbHAschaffenburg, GermanyTaking people
- Hamatologisch Onkologische Praxis Heinrich Bangerter Augsburg GbRAugsburg, GermanyTaking people
- University Hospital AugsburgAugsburg, GermanyTaking people
- Gesundheitszentrum Wetterau gGmbHBad Nauheim, GermanyTaking people
- Sozialstiftung BambergBamberg, GermanyTaking people
- Evangelisches Krankenhaus Bergisch Gladbach gGmbHBergisch Gladbach, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyTaking people
- Onkologischer Schwerpunkt Am Oskar Helene Heim MVZBerlin, GermanyTaking people
- Praxisklinik Krebsheilkunde Fuer FrauenBerlin, GermanyTaking people
- Vivantes Netzwerk fuer Gesundheit GmbHBerlin, GermanyTaking people
- Marienhospital Bottrop gGmbHBottrop, GermanyTaking people
- Diako Ev. Diakonie-Krankenhaus gGmbHBremen, GermanyTaking people
- Hamatologische Onkologische Praxis Im MedicumBremen, GermanyTaking people
- Klinikum Bremen-Mitte gGmbHBremen, GermanyTaking people
- Allgemeines Krankenhaus CelleCelle, GermanyTaking people
- Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
- Kliniken der Stadt Köln gGmbHCologne, GermanyTaking people
- University Hospital Cologne AöRCologne, GermanyTaking people
- Carl Thiem Klinikum gGmbHCottbus, GermanyTaking people
- Staedtisches Klinikum DessauDessau-Rosslau, GermanyTaking people
- Gemeinschaftspraxis Haematologie OnkologieDresden, GermanyTaking people
- Onkozentrum Dresden/FreibergDresden, GermanyTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
- MVZ Medical Center Duesseldorf GmbHDuesseldorf, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- Studienzentrale fuer das MVZ Eggenfelden e.K.Eggenfelden, GermanyTaking people
- Dr. Apel Medizinische Versorgung GmbHElxleben, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Klinikum Esslingen GmbHEsslingen am Neckar, GermanyTaking people
- AMEOS Krankenhausgesellschaft Ostholstein mbHEutin, GermanyTaking people
- Agaplesion Frankfurter Diakonie Kliniken gGmbHFrankfurt am Main, GermanyTaking people
- Klinikum Frankfurt Hochst GmbHFrankfurt Am Main, GermanyTaking people
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Schwerpunktpraxis der Gynäkologie und OnkologieFürstenwalde, GermanyTaking people
- Schwerpunktpraxis für Hämatologie und internistische Onkologie Dr. Wilke, Dr. Wagner und Dr. PetzoldFürth, GermanyTaking people
- Franziskus Hospital HarderbergGeorgsmarienhuette, GermanyTaking people
- HELIOS Klinikum Gifhorn GmbHGifhorn, GermanyTaking people
- Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
- Onkologische Schwerpunktpraxis GöttingenGöttingen, GermanyTaking people
- Klinikum Oberberg GmbHGummersbach, GermanyTaking people
- Praxis Dr. Heilmann -Gynäkologie/Medikamentöse Tumortherapie-Günzburg, GermanyTaking people
- Gemeinschaftspraxis Dr Med Regina Moeller Dr Med Tabea Appel Anett KrziwanieHalle, GermanyTaking people
- Katholisches Marienkrankenhaus gGmbHHamburg, GermanyTaking people
- Mammazentrum Hamburg MVZ GbRHamburg, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- St. Barbara-Klinik Hamm GmbHHamm, GermanyTaking people
- Klinikum Hanau GmbHHanau, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Heidelberg University Hospital AöRHeidelberg, GermanyTaking people
- SLK-Kliniken Heilbronn GmbHHeilbronn, GermanyTaking people
- Saarland University HospitalHomburg, GermanyTaking people
- Frauenarztpraxis Baerens IlsedeIlsede, GermanyTaking people
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, GermanyTaking people
- Vincentius-Diakonissen-Kliniken gAGKarlsruhe, GermanyTaking people
- Klinikverbund Allgau gGmbHKempten (Allgau), GermanyTaking people
- Staedtisches Krankenhaus Kiel GmbHKiel, GermanyTaking people
- University Medical Centre Schleswig-HolsteinKiel, GermanyTaking people
- HELIOS Klinikum Krefeld GmbHKrefeld, GermanyTaking people
- Klinikum KulmbachKulmbach, GermanyTaking people
- Dr. Vehling-Kaiser MVZ GmbHLandshut, GermanyTaking people
- Gemeinschaftspraxis Fuer Haematologie Und OnkologieLangen (Hessen), GermanyTaking people
- Gemeinschaftspraxis für Hämatologie und Onkologie LebachLebach, GermanyTaking people
- St. Elisabethen-Krankenhaus gGmbHLeipzig, GermanyTaking people
- Universitätsklinikum Leipzig AöRLeipzig, GermanyTaking people
- Kliniken Lippe GmbH, Klinikum Lippe LemgoLemgo, GermanyTaking people
- MVZ Medizinisches Versorgungszentrum Dreiländereck, Onkologische Schwerpunktpraxis LörrachLörrach, GermanyTaking people
- Onkologische Schwerpunkpraxis LörrachLörrach, GermanyTaking people
- Klinikum Magdeburg gGmbHMagdeburg, GermanyTaking people
- Universitaetsklinikum Magdeburg AöRMagdeburg, GermanyTaking people
- Marienhaus Kliniken GmbHMainz, GermanyTaking people
- Universitaetsmedizin Der Johannes Gutenberg-Universitat Mainz KöRMainz, GermanyTaking people
- OnkoNet Marburg GmbHMarburg, GermanyTaking people
- Philipps University MarburgMarburg, GermanyTaking people
- Klinikum Fichtelgebirge gGmbHMarktredwitz, GermanyTaking people
- MVZ Hamatologie-Onkologie Mayen/Koblenz GmbHMayen, GermanyTaking people
- Johannes Wesling Klinikum MindenMinden, GermanyTaking people
- Evangelisches Krankenhaus Bethesda Monchengladbach Gemeinnutzige GmbHMönchengladbach, GermanyTaking people
- Haemato-Onkologische Ueberoertliche Gemeinschaftspraxis Pasing und FuerstenfeldbruckMunich, GermanyTaking people
- Rotkreuzklinikum Muenchen gGmbHMunich, GermanyTaking people
- MVZ Media Vita am St. Franziskus Hospital MünsterMünster, GermanyTaking people
- Universitaetsklinikum Muenster AöRMünster, GermanyTaking people
- Onkologische Schwerpunktpraxis NeumarktNeumarkt, GermanyTaking people
- Suedharz Klinikum Nordhausen gGmbHNordhausen, GermanyTaking people
- medius Klinik NuertingenNuertingen, GermanyTaking people
- Klinikum NürnbergNuremberg, GermanyTaking people
- St. Vincenz-Krankenhaus GmbHPaderborn, GermanyTaking people
- Gynäkoonkologische Schwerpunktpraxis PlauenPlauen, GermanyTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, GermanyTaking people
- Studienzentrum Onkologie Ravensburg GmbHRavensburg, GermanyTaking people
- Universitaetsklinikum RegensburgRegensburg, GermanyTaking people
- Gemeinschaftspraxis für Hämatologie und Internistische Onkologie RheineRheine, GermanyTaking people
- Oncologicum RosenheimRosenheim, GermanyTaking people
- RoMed Klinikum RosenheimRosenheim, GermanyTaking people
- Agaplesion Diakonieklinikum Rotenburg gGmbHRotenburg (wümme), GermanyTaking people
- GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbHRuesselsheim Am Main, GermanyTaking people
- Altmark-Klinikum gGmbHSalzwedel, Hansestadt, GermanyTaking people
- MedCenter NordsachsenScheuditz, GermanyTaking people
- Zentrum ambulante Onkologie SchorndorfSchorndorf, GermanyTaking people
- Leopoldina Krankenhaus der Stadt Schweinfurt GmbHSchweinfurt, GermanyTaking people
- Onkologisch-Gastroenterologische Schwerpunktpraxis Innere Medizin GbRSingen (hohentwiel), GermanyTaking people
- MVZ Kloster Paradiese GbRSoest, GermanyTaking people
- Onkologische Schwerpunktpraxis SpeyerSpeyer, GermanyTaking people
- Johanniter-Krankenhaus Genthin-Stendal GmbHStendal, GermanyTaking people
- Gynäkologie Kompetenzzentrum Stralsund Gynäkologische Praxis Dr. med. Carsten HielscherStralsund, GermanyTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
- Kreiskrankenhaus Torgau Johann Kentmann gGmbHTorgau, GermanyTaking people
- Klinikum Mutterhaus der Borromaeerinnen gGmbHTrier, GermanyTaking people
- Praxisnetzwerk Haematologie und internistische Onkologie Ueberoertliche BerufsausuebungsgemeinschaftTroisdorf, GermanyTaking people
- Universitaetsklinikum TuebingenTuebingen, GermanyTaking people
- Universitatsklinikum Ulm AöRUlm, GermanyTaking people
- ÜBAG Dr. Massinger-Biebl, Biebl, Meyer-Schrott WaldkirchenWaldkirchen, GermanyTaking people
- MVZ Nordoberpfalz GmbHWeiden I.D.Opf., GermanyTaking people
- GRN Klinik WeinheimWeinheim, GermanyTaking people
- Evangelisches Krankenhaus Wesel GmbHWesel, GermanyTaking people
- Medizinische Studiengesellschaft NORD-WEST GmbHWesterstede, GermanyTaking people
- St. Josefs-Hospital Wiesbaden GmbHWiesbaden, GermanyTaking people
- Rems-Murr-Kliniken gGmbHWinnenden, GermanyTaking people
- Frauenärzte am Schloss WolfenbüttelWolfenbüttel, GermanyTaking people
- Helios Universitaetsklinikum WuppertalWuppertal, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut Für Frauengesundheit GmbH
- Trial code
- NCT05452213EU 2022-500764-35-00
- Record updated
- 27 October 2026
- Original description
The co-primary objective of this trial are estimates for the survival rates of progression free survival (PFS) at months 12 and overall survival (OS) at months 12.Read full original descriptionShow less
CAPTOR-BC: COMPREHENSIVE ANALYSIS OF SPATIAL, TEMPORAL AND MOLECULAR PATTERNS OF RIBOCICLIB EFFICACY AND RESISTANCE IN ADVANCED BREAST CANCER PATIENTS
The co-primary objective of this trial are estimates for the survival rates of progression free survival (PFS) at months 12 and overall survival (OS) at months 12.
Inclusion: 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 CDK4/6 inhibitors is allowed in the adjuvant setting); Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures; 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 ER positive and/ or PgR positive breast cancer determined by core biopsy according to local in-house standard; 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.
Exclusion: 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 not eligible for treatment with ribociclib according to SmPC or investigator’s discretion; Patients who are not treated for advanced HRpos/HER2neg breast cancer in the first line therapy setting; 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); Patients with existing or patients who are at significant risk of developing 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 who are pregnant or lactating; Patients who do not agree to collection of biospecimens samples (blood, stool, tissue).