[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053487":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":54,"collaborators":25,"id":56,"slug":25,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A","ACTIVE_COMPARATOR","Participants randomized to Sequence A will complete a normal eating intervention period, followed by a washout period, followed by a prolonged fasting intervention period.\n\nNormal eating → Washout → Prolonged fasting",[13,14],"Behavioral: Normal Eating","Behavioral: Prolonged Fasting",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence B","Participants randomized to Sequence B will complete a prolonged fasting intervention period, followed by a washout period, followed by a normal eating intervention period.\n\nProlonged fasting → Washout → Normal eating",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Normal Eating","During the normal eating intervention period, participants will follow their usual eating pattern. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Prolonged Fasting","During the prolonged fasting intervention period, participants will eat only once daily (dinner), with water, black coffee, and tea permitted during fasting hours. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Lisa Chow, MD, MS","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","612-625-8934","chow0007@umn.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Minneapolis","Minnesota","55455","United States",{"type":47,"coordinates":48},"Point",[49,50],-93.26384,44.97997,{"lat":50,"lon":49},[53],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100053487",false,"NCT07624617","Fast-Her: Fasting Effects on Breast Cancer Treatment","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed metastatic breast cancer\n* Menopausal or medically ovarian suppressed\n* Currently receiving capivasertib therapy (2 tablets twice daily, 4 days per week)\n* Stable on current capivasertib regimen for at least 2 weeks\n* an ECOG performance status of 0-1\n* BMI ≥25kg\u002Fm2\n* Able to provide informed consent\n* Willing to comply with study procedures including CGM wear, food tracking by mCC app and dietary modifications\n* Access to smartphone or tablet for mobile application use\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Uncontrolled type 2 diabetes (HbA1c \\>9.0%)\n* History of severe hypoglycemia\n* Eating disorders or contraindications to fasting\n* Pregnancy or breastfeeding\n* Significant gastrointestinal disorders affecting food absorption\n* Unable to fast for medical reasons\n* Concurrent participation in other dietary intervention studies\n* A history of significantly abnormal lab results within 4 weeks of consent date, such as hematologic (Hgb \\\u003C 10.0, platelets \\\u003C 100), hepatic (LFTs \\> 2X nl), renal (Cr \\> 1.5)","ALL","18 Years",{"count":64,"type":65},15,"ESTIMATED","INTERVENTIONAL",[68],"NA","We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.",[71],"Metastatic Breast Cancer",[73],"capivasertib","2026-07-09",{"date":76,"type":77},"2026-07-13","ACTUAL",{"date":79,"type":77},"2026-05-18",{"date":81,"type":65},"2027-07-01",{"name":5,"class":6},1]