[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598863":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Guangdong Provincial People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FMD Group","EXPERIMENTAL",null,[13],"Dietary Supplement: Fasting-mimicking diet (FMD) Group",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIETARY_SUPPLEMENT","Fasting-mimicking diet (FMD) Group","The FMD will consist of a triweekly 4-day regimen of a plant-based, calorie-restricted (827± 100 kcal on day 1；637 ± 100 kcal on days 2-4), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles. Participants receive the FMD for 2 days prior to and on the day and one day after each cycle of chemotherapy.",[9],[21],{"name":22,"affiliation":5,"role":23},"Kun Wang","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Kun Wang, PhD","CONTACT","008613922118086","gzwangkun@126.com",[31],{"facility":5,"status":11,"city":32,"state":11,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Guangzhou","China","CN",{"type":36,"coordinates":37},"Point",[38,39],113.25,23.11667,{"lat":39,"lon":38},[42],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},{"type":23,"investigatorFullName":22,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Professor","100598863","fasting-mimicking-diet-as-an-adjunct-to-neoadjuvant-chemotherapy-for-hormone-receptor-positive-breast-cancer-100598863",false,"NCT07077018","Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed ER-positive , HER2-negative invasive ductal carcinoma meeting at least one of the following:1)T1c-T2 N1 with histological grade 2 (ER 1-10%) or grade 3. 2)N2-N3 or grade 3 and\u002For Ki67 ≥40%. 3)T3-T4\n* Age 18-75 years at enrollment\n* Body mass index (BMI) ≥18.5 kg\u002Fm²\n* Adequate hematological function:1）White blood cell count\\>3.0×10⁹\u002FL.2)Absolute neutrophil count ≥1.5×10⁹\u002FL.3)Platelets ≥100×10⁹\u002FL.\n* Adequate organ function:1）Total bilirubin ≤1.5 × upper limit of normal (ULN).2）ALT\u002FAST ≤2.5 × ULN. 3）Alkaline phosphatase ≤5 × ULN.4）Creatinine clearance ≥50 mL\u002Fmin-1)\n* ECOG performance status 0-2\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Prior history of any malignancy (including contralateral breast cancer)\n* Received any prior neoadjuvant chemotherapy cycle for current diagnosis\n* Uncontrolled endocrine disorders:1)Diabetes mellitus requiring insulin or oral hypoglycemics.2)Hyper\u002Fhypothyroidism requiring medication\n* Active autoimmune disease requiring systemic immunosuppressants\n* Current use of antipsychotic medications\n* Known hypersensitivity to FMD components (e.g., soy protein, milk protein, nuts)\n* Pregnancy or lactation.","ALL","18 Years","75 Years",{"count":55,"type":56},45,"ESTIMATED","INTERVENTIONAL",[59],"NA","This is a phase II, Single-Arm Clinical Study evaluating the efficacy and safety of a fasting-mimicking diet (FMD) combined with neoadjuvant chemotherapy in patients with ER-positive, HER2-negative breast cancer.\n\nParticipants will be assigned to Intervention group: 4-day FMD cycles (827± 100kcal\u002Fday on Day 1, 637± 100kcal\u002Fday on Days 2-4) synchronized with T-EC chemotherapy.\n\nThe primary endpoint is pathological complete response (pCR) rate. Secondary endpoints include metabolic changes, immune markers, quality of life, and safety (CTCAE v5.0). A total patients will be enrolled to detect a 15% pCR improvement (25% vs. 10%, α=0.05, power=80%).",[62,63,64],"Fasting-Mimicking Diet","Breast Cancer","Neoadjuvant Chemotherapy","NOT_YET_RECRUITING","2025-07-20",{"date":68,"type":69},"2025-07-22","ACTUAL",{"date":71,"type":56},"2025-07-12",{"date":73,"type":56},"2026-12-30",{"name":5,"class":6},1]