[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635480":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":39,"overallOfficials":48,"centralContacts":52,"locations":60,"responsibleParty":78,"collaborators":20,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":20,"enrollmentInfo":90,"targetDuration":20,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":20,"overallStatus":63,"whyStopped":20,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Stool Sampling Feasibility","Proportion of enrolled participants who provide serial stool samples during the baseline and on-treatment periods, as recorded by device data and study records.","2 years",[14,17],{"measure":15,"description":16,"timeFrame":12},"Baseline Microbiome-Diarrhea Associations","Correlation between baseline gut microbiome composition and incidence of grade ≥2 diarrhea during abemaciclib therapy, as defined by CTCAE v6.0.",{"measure":18,"description":19,"timeFrame":12},"Microbiome Dynamics and Diarrhea","Correlation between longitudinal changes in gut microbiome composition during abemaciclib therapy and incidence and severity of grade ≥2 diarrhea, as defined by CTCAE v6.0.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NON_RANDOMIZED","SEQUENTIAL","SUPPORTIVE_CARE",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Observational Cohort","EXPERIMENTAL","Enrolled patients with early or advanced HR+\u002FHER2- breast cancer starting abemaciclib as per standard of care to characterize the baseline composition and longitudinal dynamics of the gut microbiome before and during treatment. Stool samples will be collected continuously using the GutLab platform, alongside clinical toxicity assessments, with a focus on identifying microbial signatures associated with the development and severity of diarrhea. No intervention will be administered.",[33],"Other: Stool Sampling",{"label":35,"type":30,"description":36,"interventionNames":37},"Dietary Intervention Cohort","Enrolled patients with early-stage HR+\u002FHER2- breast cancer. A 2-week chia seed intervention will be administered prior to initiation of abemaciclib. The goal of this high fiber intervention is to favorably modulate the gut microbiome by supporting a more diverse microbiome and reducing the risk of inflammation and dysbiosis.",[33,38],"Other: Chia Seeds",[40,44],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":20},"Stool Sampling","Stool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.).",[35,29],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":20},"Chia Seeds","In the Fiber Study cohort (Part 2), participants will be advised to consume a standardized daily serving of chia seeds (25g\u002Fday) and provided with guidance on how to integrate this into their usual diet.",[35],[49],{"name":50,"affiliation":5,"role":51},"Rita Nanda","PRINCIPAL_INVESTIGATOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":20,"email":57},"Clinical Trials Intake","CONTACT","855-702-8222","cancerclinicaltrials@bsd.uchicago.edu",{"name":50,"role":55,"phone":20,"phoneExt":20,"email":59},"rnanda@bsd.uchicago.edu",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The University of Chicago Medicine Comprehensive Cancer Center","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-87.65005,41.85003,{"lat":73,"lon":72},[76,77],{"name":54,"role":55,"phone":56,"phoneExt":20,"email":57},{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},{"type":79,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100635480","study-to-understand-relationship-between-gut-health-and-toxicities-of-hormonal-breast-cancer-treatment-100635480",false,"NCT07553234","Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment","Prospective Evaluation of the Gut Microbiome and a Pilot Dietary Intervention in Patients With HR+\u002FHER2- Breast Cancer Receiving Abemaciclib (GEMMA)","GEMMA","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial\n* Be a male or female subject 18 years of age on day of signing informed consent.\n* Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:\n\nHER2 negative in primary tumour pre-treatment by local pathology assessed according current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell), OR Immunohistochemistry (IHC) 0 or IHC 1+.\n\n* Estrogen receptor (ER) and progesterone receptors (PR) positive in primary tumour pre-treatment defined as \\>1% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.\n* Planned to undergo standard of care therapy with abemaciclib and endocrine therapy, in the adjuvant or metastatic setting (Part 1) or the adjuvant setting (Part 2).\n* Be willing to provide mandatory stool samples at baseline and on treatment.\n* The Eastern Cooperative Oncology Group (ECOG) 0-2\n\nExclusion Criteria:\n\n* Patients who are pregnant or breast-feeding\n* Current use of any investigational agents\n* Uncontrolled Ulcerative Colitis, Crohn's Disease, Malabsorption syndrome or any disease significantly affecting gastrointestinal function\n* History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.","ALL","18 Years",{"count":91,"type":92},20,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds). The study aims to evaluate the relationship between the gut microbiome (a diverse ecosystem of microorganisms that affects your health and well-being) and treatment-related gastrointestinal toxicities in patients with HR+\u002FHER2- breast cancer receiving abemaciclib plus endocrine therapy.",[98],"Breast Cancer","2026-09-23",{"date":101,"type":102},"2026-09-28","ACTUAL",{"date":104,"type":102},"2026-09-21",{"date":106,"type":92},"2030-05-03",{"name":5,"class":6},1]