[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-with-brain-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-with-brain-metastasis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100604689","phase-2-t-dxd-with-or-without-neratinib-for-her2-positive-breast-cancer-with-brain-metastasis-100604689",false,"NCT07152782","T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis","Trastuzumab Deruxtecan With or Without Neratinib for HER2-positive Unresectable and\u002For Metastatic Breast Cancer With Brain Metastasis: A Multicenter, Randomized, Open Label, Phase II Trial (THUNDER Trial)","THUNDER","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following inclusion criteria in order to be enrolled in this study:\n\n1. Female, aged 18-70 years old.\n2. ECOG score ranges from 0 to 1.\n3. Expected survival period is greater than 12 weeks.\n4. Histologically confirmed invasive HER2 positive breast cancer (HER2 IHC+++or FISH\u002FCISH positive, all samples need to be verified by the pathology department of the research center).\n5. Tumor staging: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the researcher that radical surgical resection cannot be performed.\n6. The subject has at least one lesion (measurable and\u002For unmeasurable) that has not received radiation therapy in the past.\n7. MRI or CT shows brain metastasis and meets one of the following conditions:\n\n   i) Untreated brain parenchymal metastases detected through imaging screening;\n\n   Ii) Stable or progressive brain parenchymal metastases that have undergone previous local treatment and meet one of the following conditions:\n   1. Stable imaging for ≥ 4 weeks;\n   2. New brain parenchymal metastases detected by MR or CT.\n8. Transfer treatment ≤ 2 lines, and did not receive T-DXd or nalatinib.\n9. The main organ functions are basically normal, meeting the following conditions:\n\n   1. The standard for blood routine examination should meet: HB ≥ 90g\u002FL (no blood transfusion within 14 days); ANC≥1.5×109\u002FL；PLT≥75×109\u002FL；\n   2. Biochemical tests must meet the following standards: TBIL ≤ 1.5 × ULN (upper limit of normal value); ALT and AST ≤ 3 × ULN; If there is liver metastasis, ALT and AST should be ≤ 5 × ULN; Serum Cr ≤ 1.5 × ULN, endogenous creatinine clearance rate ≥ 30mL\u002Fmin (Cockcroft Gault formula).\n10. Prior to enrollment, the use of mannitol and hormone therapy is allowed, but the medication dosage should be stable for at least one week without the need for an increase.\n11. Female participants with fertility agreed to take effective contraceptive measures until 3 months after the last use of medication.\n12. The subjects voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n\\-\n\nSubjects with any of the following conditions are not eligible for inclusion in this study:\n\n1. Transfer treatment exceeding 2 lines, or previous use of T-DXd or nalatinib.\n2. Meningeal metastasis.\n3. Brain metastases that require emergency intervention treatment, or brain metastases that require treatment with more than 3mg\u002Fd dexamethasone or equivalent drugs.\n4. A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.\n5. Due to ongoing grade ≥ 2 adverse reactions caused by previous treatments (excluding hair loss).\n6. Pregnancy period.\n7. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.\n8. Unable to swallow, chronic diarrhea, and intestinal obstruction, there are multiple factors that affect medication intake and absorption.\n9. There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid and ascites).\n10. Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to the first use of the investigational drug.\n11. Long term unhealed wounds or fractures with incomplete healing.\n12. Known subjects with active HBV or HCV infection.\n13. Active primary immunodeficiency, known to be HIV positive.\n14. Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs.\n15. A history of non communicable ILD\u002Fpneumonia requiring steroids, currently suffering from ILD\u002Fpneumonia, or unable to rule out suspected ILD\u002Fpneumonia through imaging during screening.\n16. Lung standard:\n\n    1. Pulmonary specific comorbidities with clinically significant diseases, including but not limited to any potential pulmonary diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc. within 3 months of recruitment).\n    2. Any autoimmune disease, connective tissue disease, or inflammatory disease (such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.). There are records or suspicions of lung involvement during screening. For participants participating in the study, all detailed information about the disease should be recorded in the CRF.\n    3. Previous complete lung resection surgery.\n17. Individuals with allergies, or those with a known history of allergies to the components of this medication regimen, or subjects who are allergic to other monoclonal antibodies.\n\nResearchers believe that substance abuse or medical conditions may interfere with participants' participation in clinical studies or the evaluation of clinical study results.","FEMALE","18 Years","70 Years",{"count":21,"type":22},202,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis",[28,29],"Breast Cancer With Brain Metastasis","HER2-positive Breast Cancer",[31,29,32,33],"Breast Cancer with Brain Metastasis","Trastuzumab Deruxtecan","Neratinib","NOT_YET_RECRUITING","2025-08-26",{"date":37,"type":38},"2025-09-03","ACTUAL",{"date":40,"type":22},"2025-11",{"date":42,"type":22},"2029-11",{"name":44,"class":45},"Fudan University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100604491","phase-2-t-dxd-with-or-without-bevacizumab-for-her2-low-breast-cancer-with-brain-metastasis-100604491","NCT07150208","T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis","Trastuzumab Deruxtecan With or Without Bevacizumab for HER2-low Unresectable and\u002For Metastatic Breast Cancer With Brain Metastasis: A Multicenter, Randomized, Open Label, Phase II Trial (THUMB Trial)","THUMB","Inclusion Criteria:\n\n1. ECOG score of 0 to 1.\n2. Expected survival period greater than 12 weeks.\n3. Histologically confirmed invasive HER2-low expressing breast cancer (specific definition: breast cancer patients with low expression of human epidermal growth factor receptor 2 (HER-2) as determined by pathological testing. Specifically: HER2 IHC 1+ or HER2 IHC++ with FISH\u002FCISH negative. All specimens must be verified by the pathology department of the research participating center.\n4. Tumor stage: recurrent or metastatic breast cancer; local recurrence must be confirmed by the researcher to be unable to undergo radical surgical resection.\n5. Patients must have at least one lesion that has not previously received radiation therapy (measurable and\u002For non-measurable).\n6. MRI or CT shows brain metastasis and meets one of the following conditions:\n\n   i) Untreated brain parenchymal metastasis found by imaging screening; ii) Previously locally treated stable or progressive brain parenchymal metastasis and meets one of the following conditions:a) Imaging stability ≥4 weeks; b) New brain parenchymal metastasis found by MR or CT.\n7. Received no more than 2 lines of chemotherapy after metastasis.\n8. HR-positive patients must have previously received CDK4\u002F6 inhibitor treatment, whether in the adjuvant treatment phase or in the recurrent metastatic phase.\n9. Never used T-DXd or bevacizumab before.\n10. The main organ functions are basically normal, meeting the following conditions:\n11. Blood routine examination standards must comply with: HB≥90g\u002FL (not transfused within 14 days); ANC≥1.5×10\\^9\u002FL; PLT≥75×10\\^9\u002FL;\n12. Biochemical examination must comply with the following standards: TBIL≤1.5×ULN (upper limit of normal); ALT and AST≤3×ULN; if there is liver metastasis, ALT and AST≤5×ULN; serum Cr ≤1.5×ULN, endogenous creatinine clearance rate ≥30mL\u002Fmin.\n13. Allowed to use mannitol, hormone therapy before enrollment, but the drug treatment dose can be stable for at least one week without the need for an increase.\n14. Female subjects with reproductive capacity need to use one medically recognized contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug.\n15. Subjects voluntarily join this study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Received more than 2 lines of chemotherapy.\n2. Used T-DXd or bevacizumab.\n3. Meningeal metastasis.\n4. Brain metastasis requiring emergency intervention treatment, or brain metastasis requiring treatment with more than 3mg\u002Fd of dexamethasone or equivalent medication.\n5. Clinical significant or uncontrolled cardiac disease history, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.\n6. Ongoing adverse reactions of grade \\>1 due to previous treatment. The exception is alopecia or those that the researcher believes should not be excluded. Such cases should be clearly documented in the investigator's notes.\n7. Pregnant patients.\n8. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma.\n9. Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug intake and absorption.\n10. Third space fluid accumulation (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods.\n11. Participated in another antitumor drug clinical trial within 4 weeks before the first administration of the study drug.\n12. Long-term non-healing wounds or incompletely healed fractures.\n13. Known HBV or HCV infection during the active phase or HBV DNA ≥500, or chronic phase with abnormal liver function.\n14. Active primary immunodeficiency, known HIV test positive.\n15. Uncontrolled infection requiring intravenous antibiotics, antiviral drugs, or antifungal drugs.\n16. History of (non-infectious) ILD\u002Fpneumonia requiring steroids, currently having ILD\u002Fpneumonia, or unable to exclude suspected ILD\u002Fpneumonia on imaging during screening.\n17. Pulmonary criteria:\n18. Clinically significant pulmonary comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) within 3 months of study recruitment.\n19. Any autoimmune disease, connective tissue disease, or inflammatory disease (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) with recorded or suspected pulmonary involvement during screening. All detailed information about the disease should be recorded in the CRF for participants in the study.\n20. Previous total pneumonectomy.\n21. Allergic constitution, or known history of allergy to any component of the study regimen, or allergic to other monoclonal antibodies.\n22. History of gastrointestinal bleeding within the past 6 months or a clear tendency for gastrointestinal bleeding, such as: esophageal varices at risk of bleeding, local active ulcer lesions, fecal occult blood ≥ (++) not eligible for enrollment; if fecal occult blood (+), gastroscopy is required;\n23. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before participating in this study;\n24. Urinalysis shows urine protein ≥++ or confirmed 24-hour urine protein quantitative \\>1.0g;\n25. Hypertension, and blood pressure cannot be lowered to the normal range with antihypertensive drugs (systolic blood pressure \\>140mmHg, diastolic blood pressure \\>90mmHg).\n26. Substance abuse or medical conditions that the researcher believes may interfere with the subject's participation in the clinical study or the assessment of the clinical study results.",{"count":55,"type":22},140,[25],"A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Bevicizumab in HER2-low breast cancer with brain metastasis.",[28,59],"HER2-low Expressing Breast Cancer",[31,59,32,61],"Bevacizumab","2025-08-24",{"date":64,"type":38},"2025-09-02",{"date":66,"type":22},"2025-09",{"date":68,"type":22},"2028-09",{"name":44,"class":45},1]