[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545914":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":10,"id":70,"slug":10,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":10,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (initiating 1st line CDK4\u002F6 & endocrine therapy)",null,"Patients scheduled to initiate 1st line combination therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.",[13],"Procedure: Biospecimen Collection",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 (initiating 2nd or later line of CDK4\u002F6 with or without endocrine therapy)","Patients scheduled to initiate second or later lines of therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3 (currently receiving 1st line CDK4\u002F6 and endocrine therapy)","Patients currently receiving 1st line therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn on day 15 of the next cycle after enrollment and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)","Patients scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA-approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn at baseline or the first day of the treatment cycle and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Group 5","Patients scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4\u002F6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage II or stage III adjuvant HR+ BC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,15,19,23,27],[37,38,39],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",[41],{"name":42,"affiliation":5,"role":43},"Pooja Advani, MBBS, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Mayo Clinic in Florida","RECRUITING","Jacksonville","Florida","32224-9980","United States",{"type":59,"coordinates":60},"Point",[61,62],-81.65565,30.33218,{"lat":62,"lon":61},[65,67],{"name":66,"role":47,"phone":48,"phoneExt":10,"email":49},"Clinical Trials",{"name":42,"role":43,"phone":10,"phoneExt":10,"email":10},{"type":69,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100545914",false,"NCT06388122","DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients","Inclusion Criteria:\n\n* Pre- or post-menopausal HR+ metastatic breast cancer patients who are:\n\n  * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).\n  * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.\n  * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4\u002F6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC\n\nNOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.\n\nExclusion Criteria:\n\n* Treatment including investigational agent or therapies\n* Early breast cancer diagnosis\n* Male breast cancer\n* Currently receiving treatment for other active malignancy at time of registration\n\n  * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)\n* Inability to give written informed consent","FEMALE","18 Years",{"count":78,"type":79},100,"ESTIMATED","OBSERVATIONAL","This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4\u002F6 inhibitor used for hormone receptor positive HER2 negative breast cancer.",[83,84,85,86,87,88,89,90,91],"HER2-negative Breast Cancer","Hormone-receptor-positive Breast Cancer","Metastatic Breast Cancer","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","HER2 Negative Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma","Metastatic Breast Carcinoma","2026-05-28",{"date":94,"type":95},"2026-06-01","ACTUAL",{"date":97,"type":95},"2024-04-30",{"date":99,"type":79},"2031-06-15",{"name":5,"class":6},1]