[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04968964":3,"trial-entities:NCT04968964":142,"trial-summary:NCT04968964":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":46,"sex":61,"minimum_age":62,"maximum_age":17,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":92,"locations":95,"central_contacts":133,"overall_officials":135,"references":137,"see_also_links":138},"NCT04968964","202107015","Treatment Monitoring of Patients Receiving CDK 4\u002F6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing","TK IMPACT: Treatment Monitoring of Patients Receiving CDK 4\u002F6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing: Physician Decision Impact Study","RECRUITING","2030-09-30","2026-07","2026-07-06","2022-03-07","Washington University School of Medicine","OTHER",true,"Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems.\n\nThe DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and\u002For timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.",null,[19,20],"Breast Cancer","Cancer of the Breast",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},55,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","DiviTum® TKa assay","-Determines serum enzymatic activity of TK1",[35,36],"Cohort 1: Scheduled to receive first line therapy","Cohort 2: Currently receiving first line therapy",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Study Care Plans","-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value",[41],"Medical Oncologists",[43],{"measure":44,"timeFrame":45},"Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value","Within the first 48-week period of study participation",[47,50,52,55,58],{"measure":48,"timeFrame":49},"Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values","At 12 weeks",{"measure":48,"timeFrame":51},"At 12 weeks and 24 weeks",{"measure":53,"timeFrame":54},"Number of surveillance imaging tests intended to be used and actually used, in total and by modality","Over the entire study period (estimated to be 36 months)",{"measure":56,"description":57,"timeFrame":54},"Longitudinal changes in DiviTum® TKa value dynamics","The TK trajectory of a patients will be plot against time for temporal pattern and the trajectories will be modeled via linear or non-linear mixed effects mode as appropriate. If linear mixed effects model, the longitudinal rate of change will be estimated with 95% CI to indicate growth rate of TK. If non-linear, the regression coefficients of time or time relevant terms will be estimated with 95% CI",{"measure":59,"timeFrame":60},"Cohort 1 only: DiviTum® TKa level","At 2 weeks post CDK 4\u002F6 inhibitor therapy initiation","ALL","18 Years",false,{"inclusion":65,"exclusion":84,"raw_text":91},[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline study visit.","Cohort 1 only: Scheduled to initiate standard of care first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the stated diagnosis at the time of study enrollment. Type of endocrine therapy and CDK 4\u002F6 inhibitor will be documented. Patients may also be eligible if:","Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR","Patients initiated endocrine therapy alone with ultimate intention to add CDK 4\u002F6 inhibitor therapy, OR","Patients recurred on adjuvant endocrine therapy monotherapy and are scheduled to receive next line endocrine therapy combined with CDK 4\u002F6 inhibitor. Patients may have also received CDK 4\u002F6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.","Cohort 2 only: Currently receiving first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib). Changes in endocrine therapy or CDK 4\u002F6 inhibitor agent during first-line combination therapy are permitted as long as change was not performed due to progressive disease. CDK 4\u002F6 inhibitor must have been initiated within 24 months of study enrollment, and patient must have at least stable disease (no progression) on such therapy for a minimum of 12 weeks prior to enrollment as determined by radiographic studies as deemed appropriate by the treating physician. Type of endocrine therapy and CDK 4\u002F6 inhibitor will be documented. Patients may also be eligible if they are receiving next line endocrine therapy plus CDK 4\u002F6 inhibitor therapy following:","Progression on prior endocrine therapy monotherapy in the metastatic setting, OR","Recurrence on adjuvant endocrine therapy monotherapy. Patients may have also received CDK 4\u002F6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.","Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.","At least 18 years of age.","Life expectancy \\> 6 months.","Post-menopausal status, defined as one of the following:","Age ≥ 60 years","Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more","Status post bilateral oophorectomy, total hysterectomy","Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist\u002Fantagonist or surgical bilateral oophorectomy","Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).","Currently being treated at Siteman Cancer Center by a medical oncologist participating in this trial.",[85,86,87,88,89,90],"Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.","Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol assessments or analyses are eligible for this trial as determined by treating physician and with agreement by Principal Investigator","Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.","Medical Oncologist at Siteman Cancer Center","Treating patients with metastatic or advanced unresectable invasive breast cancer","Willing to complete Study Care Plans on a serial basis during participation","Inclusion Criteria - Patients:\n\n* Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline study visit.\n* Cohort 1 only: Scheduled to initiate standard of care first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the stated diagnosis at the time of study enrollment. Type of endocrine therapy and CDK 4\u002F6 inhibitor will be documented. Patients may also be eligible if:\n\n  * Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR\n  * Patients initiated endocrine therapy alone with ultimate intention to add CDK 4\u002F6 inhibitor therapy, OR\n  * Patients recurred on adjuvant endocrine therapy monotherapy and are scheduled to receive next line endocrine therapy combined with CDK 4\u002F6 inhibitor. Patients may have also received CDK 4\u002F6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.\n* Cohort 2 only: Currently receiving first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib). Changes in endocrine therapy or CDK 4\u002F6 inhibitor agent during first-line combination therapy are permitted as long as change was not performed due to progressive disease. CDK 4\u002F6 inhibitor must have been initiated within 24 months of study enrollment, and patient must have at least stable disease (no progression) on such therapy for a minimum of 12 weeks prior to enrollment as determined by radiographic studies as deemed appropriate by the treating physician. Type of endocrine therapy and CDK 4\u002F6 inhibitor will be documented. Patients may also be eligible if they are receiving next line endocrine therapy plus CDK 4\u002F6 inhibitor therapy following:\n\n  * Progression on prior endocrine therapy monotherapy in the metastatic setting, OR\n  * Recurrence on adjuvant endocrine therapy monotherapy. Patients may have also received CDK 4\u002F6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.\n* Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.\n* At least 18 years of age.\n* Life expectancy \\> 6 months.\n* Post-menopausal status, defined as one of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more\n  * Status post bilateral oophorectomy, total hysterectomy\n  * Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist\u002Fantagonist or surgical bilateral oophorectomy\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n* Currently being treated at Siteman Cancer Center by a medical oncologist participating in this trial.\n\nExclusion Criteria - Patients:\n\n* Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol assessments or analyses are eligible for this trial as determined by treating physician and with agreement by Principal Investigator\n* Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.\n\nEligibility Criteria - Physicians:\n\n* Medical Oncologist at Siteman Cancer Center\n* Treating patients with metastatic or advanced unresectable invasive breast cancer\n* Willing to complete Study Care Plans on a serial basis during participation",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":13,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":130},"St Louis","Missouri","63110","United States",[102,107,109,112,114,116,118,120,122,124,126,128],{"name":103,"role":104,"phone":105,"email":106},"Nusayba Bagegni, M.D.","CONTACT","314-273-3022","nbagegni@wustl.edu",{"name":103,"role":108},"PRINCIPAL_INVESTIGATOR",{"name":110,"role":111},"Foluso Ademuyiwa, M.D., MPH","SUB_INVESTIGATOR",{"name":113,"role":111},"Ron Bose, M.D.",{"name":115,"role":111},"Katherine Clifton, M.D.",{"name":117,"role":111},"Andrew Davis, M.D.",{"name":119,"role":111},"Ashley Frith, M.D.",{"name":121,"role":111},"Cynthia Ma, M.D., Ph.D.",{"name":123,"role":111},"Lindsay Peterson, M.D.",{"name":125,"role":111},"Rama Suresh, M.D.",{"name":127,"role":111},"Katherine Weilbaecher, M.D.",{"name":129,"role":111},"Jingqin (Rosy) Luo, Ph.D.",{"lat":131,"lon":132},38.62727,-90.19789,[134],{"name":103,"role":104,"phone":105,"email":106},[136],{"name":103,"affiliation":13,"role":108},[],[139],{"label":140,"url":141},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":143,"biomarkers":145},[144],"Breast Carcinoma",[146],"HR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR",{"nct_id":4,"found":15,"summary":148,"prompt_version":158},{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This interventional study plans to enroll 55 participants. It is not specified if it is randomized or blinded.","completed","Monitoring Breast Cancer Treatment with DiviTum® TKa","This study is looking at a new way to monitor treatment for metastatic breast cancer that is hormone receptor-positive (HR+) and HER2-negative. You would be receiving standard treatment with CDK 4\u002F6 inhibitors. The study is testing if adding a blood test called DiviTum® TKa, which measures TK1 activity, helps doctors decide when to do other imaging tests. Doctors will record if they change their plans for your imaging tests after seeing the DiviTum® TKa results. The study aims to enroll 55 participants, but its current recruitment status is unclear. You may be eligible if you are 18 or older and have HR-positive, HER2-negative metastatic breast cancer.","The primary endpoint is measured within the first 48-week period of study participation.",106,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]