[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641609":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Liaoning Cancer Hospital & Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ADC followed by chemotherapy group","EXPERIMENTAL","Patients will receive an ADC agent as second-line treatment until disease progression or unacceptable toxicity, followed by physician's choice of chemotherapy as third-line treatment",[13,14],"Drug: Antibody drug conjugate","Drug: Chemotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Chemotherapy followed by ADC group","ACTIVE_COMPARATOR","Patients will receive physician's choice of chemotherapy as second-line treatment until disease progression or unacceptable toxicity, followed by an ADC agent as third-line treatment.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Antibody drug conjugate","The selection of ADC agents will be based on the patient's molecular subtype. For Hormone receptor (HR)+\u002FHER2-low patients, anti-HER2 ADCs such as trastuzumab deruxtecan may be used. For HR+\u002FHER2-zero patients, TROP-2-targeted ADCs such as sacituzumab govitecan are preferred. For HR-\u002FHER2-low patients, either anti-HER2 ADCs or Trophoblast cell surface antigen 2 (TROP-2) ADCs may be considered. For HR-\u002FHER2-zero patients, TROP-2 ADCs will be used. The specific ADC regimen will be determined at the discretion of the investigators.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Chemotherapy","The chemotherapy regimen will consist of standard second-line agents such as capecitabine, eribulin, vinorelbine, or gemcitabine. The specific chemotherapy regimen will be determined at the discretion of the investigators.",[9,16],[32,35],{"name":33,"affiliation":5,"role":34},"Tao Sun","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Bo Lan","National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Dan Lyu","CONTACT","0086-19800367870","lvdan9303@163.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Shenyang","Liaoning","China","CN",{"type":52,"coordinates":53},"Point",[54,55],123.43278,41.79222,{"lat":55,"lon":54},[58],{"name":5,"role":41,"phone":59,"phoneExt":26,"email":43},"86-19800367870",{"type":34,"investigatorFullName":33,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Principal Investigator",[63],{"name":64,"class":6},"National Cancer Center, China","100641609","phase-2-optimal-application-timing-of-adc-drugs-for-advanced-breast-cancer-100641609",false,"NCT07657130","Optimal Application Timing of ADC Drugs for Advanced Breast Cancer","A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients","Inclusion Criteria:\n\n1. Female patients aged 18-75 years;\n2. Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+\u002FISH-, IHC 1+\u002FISH-, and IHC 0\u002FISH- subtypes;\n3. Completed first-line combination chemotherapy for advanced\u002Fmetastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);\n4. Electrocorticography (ECOG) performance status \\\u003C 2;\n5. Estimated life expectancy ≥ 12 weeks;\n6. Adequate bone marrow function, defined as:\n\n   * ANC ≥ 1.5 × 10⁹\u002FL\n   * Platelets ≥ 90 × 10⁹\u002FL\n   * Hemoglobin ≥ 90 g\u002FL\n7. Adequate hepatic and renal function, defined as:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)\n   * Creatinine clearance ≥ 60 mL\u002Fmin\n8. Signed informed consent obtained prior to any study-related procedures or treatments, confirming the patient's willingness to participate and comply with study requirements.\n\nExclusion Criteria:\n\n1. Prior treatment with an ADC after disease recurrence or metastasis;\n2. Pregnant or breastfeeding women;\n3. No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;\n4. Symptomatic brain parenchymal and\u002For leptomeningeal metastases with symptoms not adequately controlled by treatment;\n5. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin;\n6. Psychiatric disorders or other conditions that may interfere with patient compliance;\n7. Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial\u002Fvenous thromboembolic events;\n8. Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment;\n9. Known or suspected allergy to any study drug or its excipients;\n10. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.","FEMALE","18 Years","75 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.\n\nPrimary Objective:\n\nTo compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer.\n\nSecondary Objectives:\n\nTo compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.",[83],"Breast Cancer Females",[85,23,86,87,88],"Breast cancer","Timing of application","Randomized controlled trial","HER2-negative","2026-06-17",{"date":91,"type":92},"2026-06-18","ACTUAL",{"date":94,"type":92},"2025-07-01",{"date":96,"type":77},"2026-12-30",{"name":5,"class":6},1]