[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529099":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":38,"armGroups":46,"interventions":52,"overallOfficials":64,"centralContacts":68,"locations":77,"responsibleParty":136,"collaborators":38,"id":139,"slug":38,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":38,"enrollmentInfo":147,"targetDuration":38,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":38,"overallStatus":80,"whyStopped":38,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84","Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days","Day 84",[14,18,22,26,28,31,32,34],{"measure":15,"description":16,"timeFrame":17},"How many days with Grade 2 or greater of diarrhea in the first month","Number of days with Grade 2 or greater in the first month","1 month",{"measure":19,"description":20,"timeFrame":21},"Rate of Grade 3 or greater of diarrhea in the first 3 months","Nuber of subjects who experienced Grade 3 or greater by the total number of subjects enrolled","3 months",{"measure":23,"description":24,"timeFrame":25},"Disease Free Survival (DFS)","Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death","1 year",{"measure":23,"description":24,"timeFrame":27},"2 years",{"measure":29,"description":30,"timeFrame":25},"Overall Survival (OS)","OS is defined as the time from D1 of treatment until death",{"measure":29,"description":30,"timeFrame":27},{"measure":29,"description":30,"timeFrame":33},"3 years",{"measure":35,"description":36,"timeFrame":37},"Subject reported outcomes regarding adverse events","Toxicity grade as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0","5 years",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"NA","SINGLE_GROUP","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE","Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers\n\nIn this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84",[47],{"label":48,"type":6,"description":49,"interventionNames":50},"Single arm adjuvant abemaciclib","Participants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3.",[51],"Drug: Abemaciclib",[53,58,61],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":38},"DRUG","Abemaciclib","Week 1 50mg orally BID",[48],{"type":54,"name":55,"description":59,"armGroupLabels":60,"otherNames":38},"Week 2 100mg orally BID",[48],{"type":54,"name":55,"description":62,"armGroupLabels":63,"otherNames":38},"Week 3+ 150mg orally BID",[48],[65],{"name":66,"affiliation":5,"role":67},"VK Gadi, MD, PhD","PRINCIPAL_INVESTIGATOR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":38,"email":73},"Michelle Karan","CONTACT","224-563-7137","makaran2@uic.edu",{"name":66,"role":71,"phone":75,"phoneExt":38,"email":76},"312-4135309","vkgadi@uic.edu",[78,96,116],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"University of Illinois","RECRUITING","Chicago","Illinois","60612","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-87.65005,41.85003,{"lat":90,"lon":89},[93,94],{"name":70,"role":71,"phone":72,"phoneExt":38,"email":73},{"name":66,"role":71,"phone":95,"phoneExt":38,"email":76},"312-413-5309",{"facility":97,"status":80,"city":98,"state":99,"zip":100,"country":84,"countryCode":85,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Iowa Holden Comprehensive Cancer Center","Iowa City","Iowa","52242",{"type":87,"coordinates":102},[103,104],-91.53017,41.66113,{"lat":104,"lon":103},[107,111,115],{"name":108,"role":71,"phone":109,"phoneExt":38,"email":110},"Sneha Phadke, DO","319-356-4200","sneha-phadke@uiowa.edu",{"name":112,"role":71,"phone":113,"phoneExt":38,"email":114},"Olivia Barritt","1-319-356-4200","Olivia-Barritt@uiowa.edu",{"name":108,"role":67,"phone":38,"phoneExt":38,"email":38},{"facility":117,"status":80,"city":118,"state":119,"zip":120,"country":84,"countryCode":85,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":87,"coordinates":122},[123,124],-82.99879,39.96118,{"lat":124,"lon":123},[127,131,135],{"name":128,"role":71,"phone":129,"phoneExt":38,"email":130},"Robert Wesolowski, MD","614-366-8541","Robert.Wesolowski@osumc.edu",{"name":132,"role":71,"phone":133,"phoneExt":38,"email":134},"Jenna Cody","800-293-5066","jenna.cody@osumc.edu",{"name":128,"role":67,"phone":38,"phoneExt":38,"email":38},{"type":67,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Vijayakrishna Krishnamurthy Gadi","Principal Investigator","100529099",false,"NCT06169371","Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)","BRE-09","Inclusion Criteria:\n\n* ECOG 0-2\n* Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.\n* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Chronic history of diarrhea\n* Active infection requiring systemic therapy\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Other major comorbidity as determined by study PI","ALL","18 Years",{"count":148,"type":149},50,"ESTIMATED","INTERVENTIONAL",[152],"PHASE4","This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers",[155],"Breast Cancer","2026-06-18",{"date":158,"type":159},"2026-06-23","ACTUAL",{"date":161,"type":159},"2023-12-28",{"date":163,"type":149},"2030-11",{"name":5,"class":6},3]