[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advancedmetastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advancedmetastatic-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100637795","phase-2-dalpiciclib-anti-her2-therapy-and-endocrine-therapy-for-hormone-receptor-positive-her2-positive-metastatic-breast-cancer-100637795",false,"NCT07610720","Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer","Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.\n2. Hormone receptor (HR)-positive and HER2-positive.\n3. Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.\n4. ECOG Performance Status: 0-1.\n\nExclusion Criteria:\n\n1. Symptomatic active brain metastases or extensive leptomeningeal metastases.\n2. History of Grade 3 or 4 allergic reaction related to the study drugs.\n3. Currently receiving other anti-tumor therapies.","FEMALE","18 Years","75 Years",{"count":20,"type":21},57,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.",[27,28],"Advanced\u002FMetastatic Breast Cancer","HER2-Positive Metastatic Breast Cancer",[30,31],"Dalpiciclib","Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy","RECRUITING","2026-05-20",{"date":35,"type":36},"2026-05-28","ACTUAL",{"date":38,"type":21},"2026-06-01",{"date":40,"type":21},"2029-11-01",{"name":42,"class":43},"Sun Yat-sen University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100634734","phase-3-megestrol-acetate-for-fatigue-management-in-t-dxd-treated-breast-cancer-100634734","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",{"count":54,"type":21},132,[56],"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.",[27,59],"HER2+, Low, or Ultralow Advanced\u002FMetastatic Breast Cancer",[61,62],"Megestrol Acetate","Megestrol Acetate + Trastuzumab Deruxtecan","NOT_YET_RECRUITING","2026-04-15",{"date":66,"type":36},"2026-04-22",{"date":68,"type":21},"2026-05-01",{"date":70,"type":21},"2031-04-01",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100235078","praegnant-breast-cancer-earlyadvancedmetastatic-100235078","NCT02338167","Praegnant Breast Cancer: Early\u002FAdvanced\u002FMetastatic","Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced\u002FMetastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics","PRAEGNANT","Inclusion Criteria for the early breast cancer setting:\n\n* Adult breast cancer patients (age ≥18 years)\n* Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry\n* Patients, who are able and willing to sign the informed consent form\n\nInclusion Criteria for the advanced\u002Fmetastatic setting:\n\n* Adult women aged ≥18 years\n* Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to \"non-invasive\"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and\n* Patients, who are willing and able to sign the informed consent form\n* Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)\n\nExclusion Criteria:\n\n* Patients who did not sign the informed consent form\n* Patients, who are not eligible for observation due to non-availability and\u002For severe comor-bidities as evaluated by the treating physician","ALL","99 Years",{"count":83,"type":21},13500,"60 Months","OBSERVATIONAL","Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge.\n\nRecently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected.\n\nHowever molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare.\n\nWith modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor.\n\nFurthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.",[27,88],"Breast Cancer (Early Breast Cancer)","2026-01-28",{"date":91,"type":36},"2026-01-30",{"date":93,"type":36},"2014-06",{"date":95,"type":21},"2030-07",{"name":97,"class":43},"University Hospital Tuebingen",61]