[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-brain-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-brain-metastases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100506281","phase-2-efficacy-and-safety-of-sph4336-in-combination-with-endocrine-therapy-in-breast-cancer-patients-with-brain-metastases-100506281",false,"NCT05872347","Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.","A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).\n2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n3. Life expectancy ≥ 3 months.\n4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries\u002Fother local therapies.\n5. At least one measurable lesion .\n6. Laboratory test results meet the relevant requirements for organ function.\n7. Subjects who agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer.\n2. Patients unsuitable for endocrine therapy at the investigator's discretion.\n3. Have a History of other malignancies prior to the start of study treatment.\n4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.\n5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.\n6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.\n7. Pregnant or lactating women.\n8. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.\n9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.\n10. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \\> 2,000 IU\u002FmL or \\> 10(4) copies\u002FmL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.\n11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.\n12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.\n13. Presence of uncontrolled infections before the start of study treatment.\n14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.\n15. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.","FEMALE","18 Years","75 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.",[27],"Breast Cancer Brain Metastases","RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":32},"2023-09-19",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Shanghai Pharmaceuticals Holding Co., Ltd","INDUSTRY",25,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100571336","phase-1-study-of-shr-a1811-combined-with-pyrotinib-and-bevacizumab-in-advanced-breast-cancer-with-brain-metastasis-100571336","NCT06718933","Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis","A Prospective, Single-arm, Exploratory, Phase Ib\u002FII Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis.","Inclusion Criteria:\n\n* More than 18 years old;\n* ECOG PS Score: 0\\~2;\n* Patients must have a life expectancy ≥ 3 months;\n* Brian metastasis confirmed by MRI, at least one measurable brain lesion based on RANO-BM with no prior radiotherapy;\n* Mannitol or hormone therapy is allowed to use for brain metastasis before enrolment, but treatment dosage should be stable for one week and not need to be increased;\n* Adequate organ function and marrow function;\n* Has recovered from any AEs (≤ grade 1) related to prior anti-tumour treatments before first dose of study therapy, except: a. alopecia; b. hyperpigmentation;\n* Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture;\n* Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;\n* Has CNS complications with the need for emergency intervention, or brain metastasis with poorly controlled symptoms by hormone or dehydration therapy, such as uncontrollable intracranial hypertension, mental disorder or epilepsy;\n* Prior bevacizumab or EGFR-TKI is allowed, but should meet the following requirements at the same time:\n\n  1. No disease progression during prior bevacizumab or EGFR-TKI;\n  2. More than 3 months from the interruption of bevacizumab or EGFR-TKI to disease progression;\n* Has received whole brain radiotherapy, chemotherapy, surgery within 2 weeks before first dose of study therapy; has received trastuzumab-based therapy or endocrine therapy within one week before first dose of study therapy; has received palliative radiotherapy for bone metastasis within 2 weeks before first dose of study therapy;\n* Has known clinically significant lung disease, that is, moderate-to-severe lung disease which severely affects respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonitis. Prior ≥ grade 3 interstitial lung disease is not allowed to enrolment;\n* Has received full-dose anticoagulants or thrombolytics within 10 days before enrolment, or non-steroid anti-inflammatory drugs with platelet inhibition (except low-dose aspirin (≤325mg qd) for preventive use);\n* Existence of unhealed wound, active gastric ulcer, and other diseases which may cause haemorrhage risk (e.g., prior major operation within 4 weeks before enrolment, prior arterial or venous thrombotic event within one year before enrolment, prior cerebralvascular accident);\n* Has known hereditary haemorrhagic tendency or coagulation disorder;\n* Has joined in other clinical drug trials within 2 weeks before enrolment;\n* Use of other antitumor systemic treatment during the study at the same time, except bisphosphonates for the treatment of bone metastasis or osteoporosis prevention;\n* Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;\n* Cardiac insufficiency, including but not limited to: congestive heart failure, transmural myocardial infarction, angina which needs drug treatments, clinically significant valvulopathy and high-risk arrhythmia, or QTc abnormity with clinical significance in ECG examination during the screening period (corrected QTc \\>450 msec \\[male\\] or QTc \\>470 msec \\[female\\] under the resting state);\n* Uncontrolled hypertension (under the resting state: systolic pressure \\>160mmHg or diastolic pressure \\>100mmHg);\n* Other diseases which may affect study results, including but not limited to: 1) known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation; 2) HBsAg-positive and HBV DNA≥1000 IU\u002FmL, or HCV antibody-positive, or treponema pallidum antibody-positive; 3) hypersensitivity to study therapy or any of its excipients; 4) severe infection requiring antibiotics, antiviral or antifungal treatment;\n* Female patients during the gestation or suckling period, of childbearing potential and pregnancy test-positive, or unwilling to use an effective method of contraception during the whole study;\n* Inability to swallow, intestinal obstruction or existence of other factors affecting medication and absorption;\n* Any other conditions not appropriate for study enrolment in the opinion of the investigator.","ALL",{"count":50,"type":21},74,[52,24],"PHASE1","In phase Ib, our study is aimed to evaluate the safety and tolerance of SHR-A1811 combined with pyrotinib in breast cancer with brain metastasis, and confirm the recommended phase 2 dose combined with preliminary results of efficacy.\n\nIn phase II, our study is aimed to evaluate the efficacy and safety of SHR-A1811 combined with pyrotinib and bevacizumab at RP2D in breast cancer with brain metastasis.",[55,27],"Breast Cancer Metastatic","2025-02-04",{"date":58,"type":32},"2025-02-06",{"date":60,"type":32},"2025-01-08",{"date":62,"type":21},"2027-02-28",{"name":64,"class":65},"Fudan University","OTHER",1]