[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571336":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":41,"locations":50,"responsibleParty":70,"collaborators":26,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":26,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":26,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1811+pyrotinib","EXPERIMENTAL","In phase Ib, enrolled subjects will received SHR-A1811 combined with pyrotinib at different doses to confirm RP2D and evaluate the safety and tolerance.",[13,14],"Drug: SHR-A1811","Drug: Pyrotinib",{"label":16,"type":10,"description":17,"interventionNames":18},"SHR-A1811+pyrotinib+bevacizumab","In phase II, enrolled subjects will received SHR-A1811 combined with pyrotinib and bevacizumab to evaluate the efficacy and safety.",[13,19,14],"Drug: Bevacizumab",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","SHR-A1811","ADC",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Bevacizumab","bevacizumab biosimilar",[16],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Pyrotinib","anti-HER2 inhibitor",[9,16],[36,39],{"name":37,"affiliation":5,"role":38},"Hongxia Wang, Chief physician","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"Biyun Wang, Chief physician",[42,46],{"name":37,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+8621-38196379","whx365@126.com",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},"Ting Li, Associate chief physician","+86-18121299346","cinderellaliting@126.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Fudan Cancer Hospital","RECRUITING","Shanghai","Shanghai Municipality","200230","China","CN",{"type":60,"coordinates":61},"Point",[62,63],121.45806,31.22222,{"lat":63,"lon":62},[66,67,68,69],{"name":37,"role":43,"phone":44,"phoneExt":26,"email":45},{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},{"name":37,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":40,"role":38,"phone":26,"phoneExt":26,"email":26},{"type":38,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hongxia Wang","Chief physician","100571336","phase-1-study-of-shr-a1811-combined-with-pyrotinib-and-bevacizumab-in-advanced-breast-cancer-with-brain-metastasis-100571336",false,"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","18 Years",{"count":83,"type":84},74,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","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.",[91,92],"Breast Cancer Metastatic","Breast Cancer Brain Metastases","2025-02-04",{"date":95,"type":96},"2025-02-06","ACTUAL",{"date":98,"type":96},"2025-01-08",{"date":100,"type":84},"2027-02-28",{"name":5,"class":6},1]