[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trop2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trop2":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100612306","evaluation-of-trop-2-adc-in-breast-cancer-patients-with-brain-metastases-a-real-world-study-100612306",false,"NCT07251868","Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study","Evaluation of Efficacy and Safety of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Multicenter Real-World Study","Inclusion Criteria:\n\n* At least 18 years old (based on actual age at the time of signing the informed consent form), with no restriction on gender\n* Able to understand the study purpose, risks, and benefits, and voluntarily sign the written informed consent form; if the patient has cognitive impairment or is unable to express themselves independently, their legal guardian\u002Fauthorized agent shall sign after being fully informed, and provide valid authorization documents.\n* Have access to complete medical records (including breast cancer primary lesion diagnosis data, brain metastasis diagnosis data, SG treatment records, follow-up data, etc.) in the study collaborating medical institutions\u002Fspecified medical systems to ensure traceability of treatment processes and outcomes.\n\nDiagnosed with breast cancer via histopathological\u002Fcytopathological examination, with the diagnostic report issued by a tertiary hospital or the study-designated pathology center.\n\n* Diagnosed with breast cancer brain metastasis based on meeting any of the following conditions: ① Definitive diagnosis by a physician with associate senior title or above, combining contrast-enhanced cranial magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) with clinical symptoms and signs; ② Postoperative pathology of brain metastatic lesions confirming breast cancer metastasis; ③ Pathological examination of brain metastatic lesion biopsy specimens confirming breast cancer metastasis.\n* No restrictions on the number, size of brain metastatic lesions, presence of meningeal metastasis, or presence of brain metastasis-related symptoms (e.g., headache, limb dysfunction).\n* Previous treatment with Sacituzumab Govitecan (SG), with clear medication records (prescription orders, medical orders, pharmacy dispensing records, etc.), and no restrictions on the line of SG treatment, dosage, or treatment cycles (both completion of full-cycle treatment and early discontinuation due to adverse reactions\u002Fprogression are acceptable).\n* No restriction on the start time of SG treatment ; patients currently receiving SG treatment, who have completed SG treatment, or who have discontinued SG treatment due to objective reasons are all eligible.\n* Stable vital signs at present, without the following uncontrolled severe conditions: ① Severe infections such as sepsis and severe pneumonia (symptoms relieved and laboratory indicators normalized after anti-infective treatment); ② Epileptic seizures within the past 3 months (or uncontrolled without standardized anti-epileptic treatment); ③ Failure of major organs such as heart, liver, and kidney (e.g., New York Heart Association (NYHA) Class Ⅳ cardiac function, Child-Pugh Class C liver function, chronic kidney disease Stage 5) .\n* The patient\u002Fguardian can cooperate with study follow-up (outpatient follow-up, telephone follow-up, electronic medical record extraction, etc.), and survival status, disease progression, subsequent treatment, adverse reactions, and other information can be obtained within the expected follow-up period.\n\nExclusion Criteria:\n\n* Complicated with other primary malignant tumors (excluding breast cancer), and the tumor was in an active stage within the past 5 years (not achieving complete remission or disease-free survival for more than 5 years).\n* Unable to cooperate with informed consent or follow-up due to mental illness, cognitive impairment, etc., and without qualified guardian assistance.\n* Concurrent participation in other interventional clinical trials (e.g., randomized controlled trials), which may affect data collection and result interpretation of this study.\n* Other conditions judged by the researcher to affect study quality or patient safety .","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","The goal of this real-world study (RWS) is to evaluate the effectiveness of Trop-2 ADC (sacituzumab govitecan) in treating breast cancer patients with brain metastases, and to understand the safety profile of this drug in real clinical practice across multiple centers. The main questions it aims to answer are:\n\nDoes Trop-2 ADC (sacituzumab govitecan) improve intracranial outcomes in breast cancer patients with brain metastases (e.g., intracranial objective response rate, intracranial progression-free survival)? What types and rates of adverse events do breast cancer patients with brain metastases experience when receiving Trop-2 ADC (sacituzumab govitecan)? This is a multicenter real-world study, which will collect and analyze data from breast cancer patients with brain metastases who have received Trop-2 ADC (sacituzumab govitecan) in routine clinical care (no randomization or placebo control, consistent with real-world clinical scenarios).\n\nParticipants (breast cancer patients with brain metastases who received Trop-2 ADC) will have their data collected from:\n\nElectronic health records (EHRs) across multiple medical centers Regular clinical follow-up visits (e.g., once every 4-8 weeks) for imaging assessments (to evaluate brain metastasis changes) and safety monitoring Medical records documenting treatment responses, disease progression, and any adverse events during treatment and follow-up",[24,25,26],"Breast Cancer","Brain Metastases From Breast Cancer","Trop2",[28,29,26,30],"breast cancer","Brain metastases","sacituzumab govitecan","RECRUITING","2025-11-24",{"date":34,"type":35},"2025-11-26","ACTUAL",{"date":37,"type":35},"2024-08-01",{"date":39,"type":20},"2027-12-31",{"name":41,"class":42},"Peking University Cancer Hospital & Institute","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100604621","petct-for-trop2-adc-response-evaluation-nsclc-100604621","NCT07151898","PET\u002FCT for Trop2 ADC Response Evaluation NSCLC","Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET\u002FCT in NSCLC","Inclusion Criteria:\n\n* adult patients (aged 18 years or order)\n* histologically or cytologically confirmed metastatic NSCLC previously treated with systemic therapy, supported by imaging (e.g. CT, MRI), tumor markers, or pathology reports\n* presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\n* willingness to undergo serial 68Ga-MY6349 PET\u002FCT scans before and during Trop2-ADC therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee\n\nExclusion Criteria:\n\n* Evidence of significantly impaired hepatic or renal function\n* Estimated life expectancy of less than 3 months",{"count":52,"type":20},50,"To evaluate whether serial 68Ga-MY6349 PET\u002FCT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in NSCLC patients.",[55,26,56],"NSCLC","PET\u002FCT",[55,26,56,58],"Trop2-ADC","2025-08-26",{"date":61,"type":35},"2025-09-03",{"date":63,"type":35},"2025-05-01",{"date":65,"type":20},"2027-05-01",{"name":67,"class":42},"The First Affiliated Hospital of Xiamen University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":43},"100596532","petct-for-trop2-adc-response-evaluation-cancers-100596532","NCT07046689","PET\u002FCT for Trop2 ADC Response Evaluation Cancers","Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET\u002FCT in Advanced Breast Cancer","Inclusion Criteria:\n\n* adult patients (aged 18 years or order)\n* histologically or cytologically confirmed metastatic breast cancer previously treated with systemic therapy, supported by imaging (e.g., MRI, CT), tumor markers, or pathology reports\n* presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\n* willingness to undergo serial 68Ga-MY6349 PET\u002FCT scans before and during Trop2-ADC therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee\n\nExclusion Criteria:\n\n* Evidence of significantly impaired hepatic or renal function\n* Estimated life expectancy of less than 3 months","FEMALE",{"count":52,"type":20},"To evaluate whether serial 68Ga-MY6349 PET\u002FCT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients.",[24,26,56],[80,26,56,58],"Breast cancer","2025-07-14",{"date":83,"type":35},"2025-07-15",{"date":85,"type":35},"2024-11-01",{"date":87,"type":20},"2026-12-31",{"name":67,"class":42},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":107,"locationsCount":43},"100596533","68ga-my6349-petct-in-solid-tumors-100596533","NCT07046702","68Ga-MY6349 PET\u002FCT in Solid Tumors","68Ga-MY6349 PET\u002FCT in Solid Tumors and Compared With 18F-FDG PET\u002FCT","Inclusion Criteria:\n\n* adult patients (aged 18 years or older)\n* patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report)\n* patients who had scheduled both standard-of-care imaging and 68Ga-MY6349 PET\u002FCT scans\n* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee\n\nExclusion Criteria:\n\n* patients with pregnancy\n* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent",{"count":97,"type":20},300,"The objective of the study is to construct a noninvasive approach 68Ga-MY6349 PET\u002FCT to detect the Trop-2 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from Trop-2 PET\u002FCT.",[100,26,56],"Solid Tumor",[102,26,56],"Solid tumor",{"date":83,"type":35},{"date":105,"type":35},"2024-12-10",{"date":87,"type":20},{"name":67,"class":42}]