[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607599":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":10,"enrollmentInfo":38,"targetDuration":10,"studyType":41,"phases":10,"briefSummary":42,"conditions":43,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Women with advanced HR-positive\u002FHer2-negative Breast Cancer",null,"Women with advanced HR-positive\u002FHer2-negative Breast Cancer (BC) who have completed at least 2 cycles of a first-line therapy with CDK4\u002F6i + hormone therapy and are currently on treatment.",[13],"Other: Home questionnaire",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Home questionnaire","Administration of a questionnaire at each 28-days cycle, to select patients who need to access to hospital for clinical visit during treatment with CDK4\u002F6i + hormone therapy for advanced breast cancer.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"IDA PARIS","CONTACT","+39 06 30151","senogin@policlinicogemelli.it",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Paris Ida","Head of Unit","100607599","development-of-a-new-remote-monitoring-model-for-patients-with-hrher2--breast-cancer-in-treatment-with-cdk46-inhibitors-and-hormone-therapy-100607599",false,"NCT07190651","Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4\u002F6 Inhibitors and Hormone Therapy","VIRTUOSA","Inclusion Criteria:\n\n* Written informed consent.\n* Age ≥18 years old\n* Histologically or cytologically documented diagnosis of HR+, HER2-negative breast cancer based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent. HR+ tumor is defined as ER and\u002For PgR expression in greater than 1% of tumor cells. HER2-negative breast cancer is 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).\n* Currently on treatment and have received ≥ 2 months of CDK4\u002F6i + hormone therapy as their initial endocrine based treatment for their metastatic disease in concordance with local CDK4\u002F6i label or treatment guideline.\n* No evidence of clinical or radiological disease progression per investigator assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.\n\nExclusion Criteria:\n\n* History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.\n* Patient has a concurrent invasive malignancy and \u002For is concurrently using other anti-neoplastic therapy.","FEMALE","18 Years",{"count":39,"type":40},50,"ESTIMATED","OBSERVATIONAL","This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4\u002F6i, to improve patients' quality of life and reduce burden of hospital accesses.",[44,45],"Breast Cancer","CDK4\u002F6 Inhibitor","NOT_YET_RECRUITING","2025-09-17",{"date":49,"type":50},"2025-09-24","ACTUAL",{"date":52,"type":40},"2025-10-01",{"date":54,"type":40},"2026-09-30",{"name":5,"class":6}]