[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-low-or-ultralow-advancedmetastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-low-or-ultralow-advancedmetastatic-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":21,"type":22},132,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Advanced\u002FMetastatic Breast Cancer","HER2+, Low, or Ultralow Advanced\u002FMetastatic Breast Cancer",[31,32],"Megestrol Acetate","Megestrol Acetate + Trastuzumab Deruxtecan","NOT_YET_RECRUITING","2026-04-15",{"date":36,"type":37},"2026-04-22","ACTUAL",{"date":39,"type":22},"2026-05-01",{"date":41,"type":22},"2031-04-01",{"name":43,"class":44},"Sun Yat-sen University","OTHER"]