[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634734":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Megestrol Acetate + Trastuzumab Deruxtecan",[13],"Drug: Megestrol Acetate + Trastuzumab Deruxtecan",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Placebo + Trastuzumab Deruxtecan",[19],"Drug: Placebo + Trastuzumab Deruxtecan",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Megestrol Acetate 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg\u002Fkg IV infusion every 3 weeks",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Matched placebo 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg\u002Fkg IV infusion every 3 weeks",[15],[30],{"name":31,"affiliation":32,"role":33},"Jiajia Huang, PhD \u002F Doctorate","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Meiting Chen Doctor, PhD \u002F Doctorate","CONTACT","02087341812","chenmt@sysucc.org.cn",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Sun yat-Sen University Cancer Center","Guangzhou","Yuexiu District","510060","China","CN",{"type":49,"coordinates":50},"Point",[51,52],113.25,23.11667,{"lat":52,"lon":51},{"type":33,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jia-Jia Huang","Department of Medical Oncology Professor, Principal Investigator, Chief Physician","100634734","phase-3-megestrol-acetate-for-fatigue-management-in-t-dxd-treated-breast-cancer-100634734",false,"NCT07543536","Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer","A Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Trial Evaluating Megestrol Acetate for the Management of Fatigue in Advanced Breast Cancer Patients Treatment With Trastuzumab Deruxtecan","MEGA-TACT-BC3","Inclusion Criteria:\n\n1. Female, aged 18-75 years\n2. Pathologically confirmed inoperable or metastatic breast cancer with complete ER, PR, and HER2 status\n3. HER2-positive (IHC 3+ or IHC 2+ with FISH positive), HER2-low (IHC 1+ or IHC 2+ with FISH negative), or HER2-ultralow (IHC 0 with ≤10% weak incomplete membrane staining) \\[most recent specimen used\\]\n4. Investigator-assessed indication for Trastuzumab Deruxtecan (T-DXd) therapy\n5. No prior treatment with Trastuzumab Deruxtecan\n6. Received ≤5 lines (including 5 lines) of prior chemotherapy\n7. ECOG Performance Status 0-1\n8. Estimated life expectancy ≥12 weeks\n9. Adequate organ function\n10. Reliable contraception or negative serum\u002Furine pregnancy test within 7 days prior to enrollment; willing to use appropriate contraception during study and for 8 weeks after last dose\n11. Voluntary participation with good compliance\n\nExclusion Criteria:\n\n1. Severe underlying disease, comorbidities, active infection, or severe metabolic disorders\n2. Clinically significant severe fatigue at baseline (FACIT-F score \\\u003C30)\n3. Currently receiving other antitumor therapies\n4. Pregnant or lactating patients\n5. Poor compliance or unable to complete normal follow-up\n6. History of allergy to megestrol acetate or other components of the formulation\n7. History of thromboembolism (use with caution)\n8. Other malignancies diagnosed within 5 years, except: resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally radically treated prostate cancer, surgically radically treated ductal carcinoma in situ, or malignancies diagnosed \\>2 years ago with no current disease evidence and untreated for ≤2 years before randomization\n9. Any condition judged by investigator that may affect study conduct or outcome assessment","FEMALE","18 Years","75 Years",{"count":69,"type":70},132,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of life for advanced breast cancer patients.",[76,77],"Advanced\u002FMetastatic Breast Cancer","HER2+, Low, or Ultralow Advanced\u002FMetastatic Breast Cancer",[79,11],"Megestrol Acetate","NOT_YET_RECRUITING","2026-04-15",{"date":83,"type":84},"2026-04-22","ACTUAL",{"date":86,"type":70},"2026-05-01",{"date":88,"type":70},"2031-04-01",{"name":5,"class":6},1]