[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut fuer Frauengesundheit\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,64,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100647387","evaluating-the-effectiveness-of-typology-based-coaching-on-patients-therapy-management-100647387",false,"NCT07708571","Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management","A Randomized Controlled Study Evaluating the Effectiveness of Typology-based Coaching on Therapy Management for Patients With HRpos\u002FHER2neg Early Breast Cancer Under Adjuvant Treatment With Ribociclib","TYPER","Inclusion Criteria:\n\n* Participant provides written informed consent prior to the beginning of trial-specific procedures.\n* Patients must be aged ≥18 years on the day of signing informed consent.\n* Participant has histologically confirmed primary invasive adenocarcinoma of the breast.\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of ER-positive and\u002For progesterone receptor-positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory.\n* Participant has HER2neg breast cancer defined as a negative ISH test or an IHC status of 0, 1+, or 2+. If the IHC is 2+, a negative ISH (e.g., FISH, CISH, SISH, or DISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.\n* Indication for treatment with ribociclib in combination with an aromatase inhibitor for early breast cancer according to the valid SmPC.\n* Participant has adequate organ function amenable for treatment with ribociclib as assessed by a local laboratory.\n* Female participants of childbearing potential must have had a hysterectomy or be willing to use highly effective methods of contraception and have a confirmed negative pregnancy test as assessed by local in-house standard.\n* Participant is willing and able to comply with scheduled visits, treatment plans, and other trial procedures.\n\nExclusion Criteria:\n\n* Patients with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Patients with serious preexisting medical condition(s) that would preclude participation in this study.\n* Women who are pregnant or lactating.\n* Patients with active bacterial infections (requiring IV antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (e.g., known human immunodeficiency virus positivity or known active hepatitis B or C, such as hepatitis B surface antigen-positive\\]).\n* Patients with a personal history in the past 5 years of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Patients with contraindications against ribociclib according to the current SmPC.\n* Patients with hypersensitivity to active substance of ribociclib, peanuts, soya or one of the other ingredients\n* Patients who are not eligible for the trial due to severe comorbidities other than those mentioned above or unavailability according to the treating physician.","ALL","18 Years",{"count":20,"type":21},548,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib. Researchers will compare the time to permanent treatment discontinuation of patients receiving personalized coaching to the time to permanent treatment discontinuation of patients who only receive standard of care education and counselling, to see if adherence to treatment can be improved by personalized patient coaching.",[27],"HR+\u002FHER2- Early Breast Cancer","RECRUITING","2026-07-13",{"date":31,"type":32},"2026-07-16","ACTUAL",{"date":34,"type":32},"2025-11-04",{"date":36,"type":21},"2030-06",{"name":38,"class":39},"Institut fuer Frauengesundheit","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100633823","patient-relevant-outcomes-improvement-program-in-high-risk-hormone-receptor-positive-hr-breast-cancer-100633823","NCT07531693","Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer","Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer","PROSPER","Inclusion Criteria:\n\n* Femal patients age 18 or older at time of informed consent\n* Confirmed diagnosis of HR+\u002FHER2- early breast cancer (no distant metastasis)\n* Prescribed abemaciclib therapy according to the Summary of Product Characteristics (SmPC)\n* Abemaciclib therapy occured between January 1st, 2023 and June 30th, 2025\n\nExclusion Criteria:\n\n* Locally advanced or metastatic breast cancer\n* Male patients\n* Patients with contraindication(s) for abemaciclib therapy according to SmPC","FEMALE",{"count":51,"type":21},200,"OBSERVATIONAL","The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.",[27],"2026-05-11",{"date":57,"type":32},"2026-05-14",{"date":59,"type":32},"2026-02-19",{"date":61,"type":21},"2027-03",{"name":38,"class":39},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":49,"minAge":4,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":84,"locationsCount":63},"100633016","implementing-patients-competence-in-oral-ebc-therapy-persistence-100633016","NCT07521202","IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE","A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.","IMPACT PT","Inclusion Criteria:\n\n* Women age 18 or older at time of ICF signature\n* Patients with HRpos\u002FHER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago\n* Patients treated with abemaciclib according to the SmPC and each center´s medical practice\n* Informed consent given prior to the starting study activities\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Patients with contraindications against abemaciclib according to the current SmPC\n* Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician",{"count":73,"type":21},257,[24],"The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.\n\nThe main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care.\n\nParticipants will be asked to answer several questionnaires.",[27],"NOT_YET_RECRUITING","2026-04-07",{"date":80,"type":32},"2026-04-09",{"date":82,"type":21},"2026-06",{"date":36,"type":21},{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100474001","phase-4-comprehensive-analysis-of-spatial-temporal-and-molecular-patterns-of-ribociclib-efficacy-and-resistance-in-advanced-breast-cancer-patients-100474001","NCT05452213","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","CAPTOR-BC","Inclusion Criteria:\n\n1. 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\u002F6 (CDK4\u002F6) inhibitors is allowed in the adjuvant setting)\n2. Written informed consent prior to beginning of trial specific procedures\n3. Subject must be female and aged ≥ 18 years on the day of signing informed consent\n4. Locally advanced or metastatic breast cancer not amenable to curative treatment\n5. 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\n6. Histologically confirmed estrogen receptor (ER) positive and\u002F or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.\n7. corrected QT (QTcF) interval \\\u003C 450 ms\n8. Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory\n9. 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.\n10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Concurrent participation in a study with an investigational agent\u002Fdevice or within 14 days of study entry or 5 half-lives of the respective investigational agent\u002Fdevice, whichever is longer\n2. Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.\n3. Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion\n4. Patients who are pregnant or lactating.\n5. Patients with existing or patients who are at significant risk of developing corrected QT interval (QTc) prolongation. This includes\n\n   * patients with long QT syndrome\n   * uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia\n   * electrolyte abnormalities\n6. Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.\n7. 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).\n8. 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).\n9. Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)",{"count":94,"type":21},1000,[96],"PHASE4","This is a single-arm, open-label phase IV study of patients with advanced HR+\u002FHER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.",[99,100,101,102,103,104,105],"Breast Cancer","Breast Neoplasms","Breast Neoplasm Female","Breast Cancer Female","HER2-negative Breast Cancer","Hormone Receptor-positive Breast Cancer","Advanced Breast Cancer","2023-04-14",{"date":108,"type":32},"2023-04-18",{"date":110,"type":32},"2022-10-12",{"date":112,"type":21},"2026-10",{"name":38,"class":39},52,""]