[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484012":3},{"organization":4,"armGroups":7,"interventions":259,"overallOfficials":390,"centralContacts":394,"locations":399,"responsibleParty":423,"collaborators":271,"id":426,"slug":427,"hasResults":428,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":428,"sex":434,"minAge":435,"maxAge":436,"enrollmentInfo":437,"targetDuration":271,"studyType":440,"phases":441,"briefSummary":443,"conditions":444,"keywords":271,"overallStatus":402,"whyStopped":271,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":464},{"fullName":5,"class":6},"Fudan University","OTHER",[8,16,23,27,31,35,40,43,50,54,59,63,68,72,76,79,84,87,91,96,100,103,108,112,117,120,123,126,130,133,136,139,142,148,151,155,160,165,169,173,176,179,182,185,189,194,197,200,203,206,210,214,217,221,225,228,233,236,239,243,246,250,255],{"label":9,"type":10,"description":11,"interventionNames":12},"L1-1","EXPERIMENTAL","If patients were hormone receptor-positive (HR+) and HER2-negative (HER2-) defined as similarity network fusion 1(SNF1) subtype",[13,14,15],"Drug: Dalpiciclib","Drug: Goserelin","Drug: Letrozole",{"label":17,"type":18,"description":19,"interventionNames":20},"L1-2","ACTIVE_COMPARATOR","If patients were HR+HER2- with SNF1 subtype",[21,22],"Drug: Nab paclitaxel","Drug: Carboplatin",{"label":24,"type":18,"description":25,"interventionNames":26},"L2-2","If patients were HR+HER2- with SNF2 subtype",[21,22],{"label":28,"type":18,"description":29,"interventionNames":30},"L3-2","If patients were HR+HER2- with SNF3 subtype",[21,22],{"label":32,"type":18,"description":33,"interventionNames":34},"L4-2","If patients were HR+HER2- with SNF4 subtype",[21,22],{"label":36,"type":10,"description":37,"interventionNames":38},"L4-low-1","If patients were HR+HER2-low with SNF4 subtype",[39],"Drug: SHR-A1811",{"label":41,"type":18,"description":37,"interventionNames":42},"L4-low-2",[21,22],{"label":44,"type":10,"description":45,"interventionNames":46},"TN1-1","If patients were triple-negative breast cancer with immunomodulatory (IM) subtype",[47,21,22,48,49],"Drug: Camrelizumab","Drug: Epirubicin","Drug: Cyclophosphamide",{"label":51,"type":18,"description":52,"interventionNames":53},"TN1-2","If patients were triple-negative breast cancer with IM subtype",[21,22,48,49],{"label":55,"type":10,"description":56,"interventionNames":57},"TN2-1","If patients were triple-negative breast cancer with basal-like immune suppressed (BLIS) subtype",[21,22,48,49,58],"Drug: Fluzoparib",{"label":60,"type":18,"description":61,"interventionNames":62},"TN2-2","If patients were triple-negative breast cancer with BLIS subtype",[21,22,48,49],{"label":64,"type":10,"description":65,"interventionNames":66},"TN3-1","If patients were triple-negative breast cancer with androgen receptor positive HER2 activated (AR HER2) subtype",[67,21,22,48,49],"Drug: Pyrotinib",{"label":69,"type":18,"description":70,"interventionNames":71},"TN3-2","If patients were triple-negative breast cancer with AR HER2 subtype",[21,22,48,49],{"label":73,"type":10,"description":74,"interventionNames":75},"TN4-1.1","If patients were HR-HER2-low",[39],{"label":77,"type":18,"description":74,"interventionNames":78},"TN4-2",[21,22,48,49],{"label":80,"type":10,"description":81,"interventionNames":82},"TN5-1.1","If patients were triple-negative breast cancer with other subtypes",[83],"Drug: 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(SNF4) subtype",[21,22,116],"Drug: Apatinib",{"label":118,"type":10,"description":81,"interventionNames":119},"TN5-1.2",[107,83],{"label":121,"type":10,"description":89,"interventionNames":122},"H1-1.2",[39],{"label":124,"type":10,"description":98,"interventionNames":125},"H2-1.2",[67,39],{"label":127,"type":10,"description":74,"interventionNames":128},"TN4-1.2",[39,47,129],"Drug: Famitinib",{"label":131,"type":10,"description":105,"interventionNames":132},"L2-1.1",[13,14,15],{"label":134,"type":10,"description":105,"interventionNames":135},"L2-1.3",[107,21,22,129],{"label":137,"type":10,"description":110,"interventionNames":138},"L3-1.1",[13,14,15],{"label":140,"type":10,"description":114,"interventionNames":141},"L4-1.1",[83],{"label":143,"type":10,"description":144,"interventionNames":145},"L5-1","If patients were HR+HER2-",[49,146,147],"Drug: HB1801","Drug: 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Ivonescimab",{"label":170,"type":10,"description":171,"interventionNames":172},"TN6-1","TNBC",[39,107,129],{"label":174,"type":10,"description":171,"interventionNames":175},"TN6-2",[39,107],{"label":177,"type":10,"description":74,"interventionNames":178},"TN7-1",[158,159],{"label":180,"type":10,"description":74,"interventionNames":181},"TN7-2",[158,159,163],{"label":183,"type":10,"description":171,"interventionNames":184},"TN8",[158,164],{"label":186,"type":10,"description":171,"interventionNames":187},"TN9",[22,48,49,188],"Drug: paclitaxel",{"label":190,"type":10,"description":191,"interventionNames":192},"H3","If patients were HER2+",[193],"Drug: JSKN003",{"label":195,"type":10,"description":191,"interventionNames":196},"H4-1",[39,94,95,21,22],{"label":198,"type":10,"description":191,"interventionNames":199},"H4-2",[39],{"label":201,"type":10,"description":191,"interventionNames":202},"H4-3",[94,95,21,22],{"label":204,"type":10,"description":191,"interventionNames":205},"H4-4",[67,39],{"label":207,"type":10,"description":191,"interventionNames":208},"H5",[39,209],"Drug: SHR-4602",{"label":211,"type":10,"description":191,"interventionNames":212},"H6-1",[39,213],"Drug: HRS-4508",{"label":215,"type":10,"description":191,"interventionNames":216},"H6-2",[39,94,213],{"label":218,"type":10,"description":144,"interventionNames":219},"L10",[21,48,49,220],"Drug: JS207",{"label":222,"type":10,"description":89,"interventionNames":223},"H8-1",[39,14,15,224],"Drug: HRS-6209",{"label":226,"type":10,"description":89,"interventionNames":227},"H8-2",[39,14,15],{"label":229,"type":10,"description":230,"interventionNames":231},"TN10","If patients 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Patients are stratified using an established digital pathology-based AI model that predicts sensitivity to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib. Patients predicted to be sensitive (TN11-1) receive this combination therapy directly.",[47,22,129,188],{"label":251,"type":10,"description":252,"interventionNames":253},"TN11-2: TNBC patients predicted non-sensitive to Paclitaxel+Carboplatin+Camrelizumab+Famitinib by AI","TNBC patients predicted to be non-sensitive (TN11-2) to the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib first undergo stereotactic body radiation therapy (SBRT). SBRT is delivered to the primary tumor in 3 fractions of 8 Gy (total 24 Gy) over 3-5 days. Following SBRT, patients receive the combination therapy of Paclitaxel, Carboplatin, Camrelizumab and Famitinib.",[47,22,129,188,254],"Radiation: Stereotactic Body Radiation Therapy (SBRT)",{"label":256,"type":10,"description":257,"interventionNames":258},"L12","Patients with HR+HER2- breast cancer, clinical stage cT1c-4, cN0-3, M0, with either tumor grade ≥2 or Ki-67 ≥20%. Patients first undergo stereotactic body radiotherapy (SBRT) to the primary tumor, followed by combination therapy of Paclitaxel + Epirubicin + Cyclophosphamide + Camrelizumab + Famitinib.",[47,48,49,129,188,254],[260,267,272,276,280,286,290,293,296,300,304,308,311,314,317,323,327,330,334,338,342,346,350,354,358,361,364,368,371,374,378,382,385],{"type":261,"name":262,"description":263,"armGroupLabels":264,"otherNames":265},"DRUG","Dalpiciclib","an oral cyclin-dependent kinases (CDK) 4\u002F6 inhibitor",[9,131,137],[266],"SHR-6390",{"type":261,"name":268,"description":269,"armGroupLabels":270,"otherNames":271},"Pyrotinib","an irreversible dual pan-erbb receptor tyrosine kinase receptor tyrosine kinase (ERBB) inhibitor",[88,97,124,204,64],null,{"type":261,"name":273,"description":274,"armGroupLabels":275,"otherNames":271},"SHR-A1811","an anti-HER2 antibody-drug conjugate (ADC)",[88,121,124,195,198,204,207,211,215,222,226,237,36,152,73,127,170,174,244],{"type":261,"name":277,"description":278,"armGroupLabels":279,"otherNames":271},"SHR-1316","an anti-programmed death ligand 1 (PD-L1) antibody",[104,134,152,118,170,174,244],{"type":261,"name":281,"description":282,"armGroupLabels":283,"otherNames":284},"Camrelizumab","an anti-programmed death-1 (PD1) antibody",[256,44,247,251,127],[285],"SHR-1210",{"type":261,"name":287,"description":288,"armGroupLabels":289,"otherNames":271},"SHR-A1921","Trophoblast cell-surface antigen 2 (TROP2) ADC",[140,80,118],{"type":261,"name":291,"description":291,"armGroupLabels":292,"otherNames":271},"Pertuzumab",[92,240,101,195,201,215,237],{"type":261,"name":294,"description":294,"armGroupLabels":295,"otherNames":271},"Trastuzumab",[92,101,195,201,237],{"type":261,"name":297,"description":298,"armGroupLabels":299,"otherNames":271},"Goserelin","goserelin",[222,226,9,131,137],{"type":261,"name":301,"description":302,"armGroupLabels":303,"otherNames":271},"Letrozole","letrozole",[222,226,9,131,137],{"type":261,"name":305,"description":306,"armGroupLabels":307,"otherNames":271},"Nab paclitaxel","Albumin paclitaxel",[92,101,195,201,17,218,104,134,24,109,28,113,32,41,166,44,51,55,60,64,69,77,85,244],{"type":261,"name":309,"description":309,"armGroupLabels":310,"otherNames":271},"Carboplatin",[92,101,195,201,17,104,134,24,109,28,113,32,41,166,44,51,247,251,55,60,64,69,77,85,244,186],{"type":261,"name":312,"description":312,"armGroupLabels":313,"otherNames":271},"Epirubicin",[218,256,166,44,51,55,60,64,69,77,85,186],{"type":261,"name":315,"description":315,"armGroupLabels":316,"otherNames":271},"Cyclophosphamide",[218,256,143,149,166,44,51,55,60,64,69,77,85,186],{"type":261,"name":318,"description":319,"armGroupLabels":320,"otherNames":321},"Fluzoparib","an original poly adenosine diphosphate-ribose polymerase (PARP) inhibitor",[109,55],[322],"SHR-3162",{"type":261,"name":324,"description":325,"armGroupLabels":326,"otherNames":271},"Apatinib","tyrosine kinase inhibitors",[113],{"type":261,"name":328,"description":325,"armGroupLabels":329,"otherNames":271},"Famitinib",[256,134,152,156,247,251,127,170],{"type":261,"name":331,"description":332,"armGroupLabels":333,"otherNames":271},"HB1801","Albumin docetaxel",[143,149],{"type":261,"name":335,"description":336,"armGroupLabels":337,"otherNames":271},"LEM","liposome-entrapped mitoxantrone",[143,149],{"type":261,"name":339,"description":340,"armGroupLabels":341,"otherNames":271},"TQB2102","an anti-HER2 ADC",[156,161,177,180,183],{"type":261,"name":343,"description":344,"armGroupLabels":345,"otherNames":271},"Benmelstobart","an anti-PDL1 antibody",[156,177,180],{"type":261,"name":347,"description":348,"armGroupLabels":349,"otherNames":271},"Anlotinib","an tyrosine kinase inhibitor",[161,180],{"type":261,"name":351,"description":352,"armGroupLabels":353,"otherNames":271},"TQB2868","anti-PD-1\u002FTGF-βRII",[161,183],{"type":261,"name":355,"description":356,"armGroupLabels":357,"otherNames":271},"Ivonescimab","an anti-PD-1\u002FVEGF bispecific antibody",[166],{"type":261,"name":359,"description":356,"armGroupLabels":360,"otherNames":271},"JS207",[218,234,229],{"type":261,"name":362,"description":340,"armGroupLabels":363,"otherNames":271},"JSKN003",[190],{"type":261,"name":365,"description":366,"armGroupLabels":367,"otherNames":271},"HRS-4508","an HER2 inhibitor",[211,215],{"type":261,"name":369,"description":340,"armGroupLabels":370,"otherNames":271},"SHR-4602",[207],{"type":261,"name":372,"description":372,"armGroupLabels":373,"otherNames":271},"paclitaxel",[237,256,247,251,186],{"type":261,"name":375,"description":376,"armGroupLabels":377,"otherNames":271},"HRS-6209","an oral cyclin-dependent kinases 4 (CDK4) inhibitor",[222],{"type":261,"name":379,"description":380,"armGroupLabels":381,"otherNames":271},"9MW2821","a Nectin-4 antibody-drug conjugate (ADC)",[234,229],{"type":261,"name":383,"description":340,"armGroupLabels":384,"otherNames":271},"IBI354",[240],{"type":386,"name":387,"description":388,"armGroupLabels":389,"otherNames":271},"RADIATION","Stereotactic Body Radiation Therapy (SBRT)","Stereotactic Body Radiation Therapy (SBRT) is performed within 5 calendar days prior to the initiation of drug therapy. SBRT is delivered to the primary tumor in 3 fractions of 8 Gy each (total 24 Gy) over 3-5 days.",[256,251],[391],{"name":392,"affiliation":5,"role":393},"Zhimin Shao, Professor","PRINCIPAL_INVESTIGATOR",[395],{"name":392,"role":396,"phone":397,"phoneExt":271,"email":398},"CONTACT","+86(021)64175590","zhimingshao@yahoo.com",[400],{"facility":401,"status":402,"city":403,"state":404,"zip":405,"country":406,"countryCode":407,"cosmosGeoPoint":408,"geoPoint":413,"contacts":414},"Fudan University Shanghai Cancer Center Shanghai, China, 200032","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":409,"coordinates":410},"Point",[411,412],121.45806,31.22222,{"lat":412,"lon":411},[415,419],{"name":416,"role":396,"phone":417,"phoneExt":418,"email":398},"Zhimin Shao, M.D.","+86-021-64175590","88807",{"name":420,"role":396,"phone":417,"phoneExt":421,"email":422},"Min He, M.D","88603","minsmiler@126.com",{"type":393,"investigatorFullName":424,"investigatorTitle":425,"investigatorAffiliation":5,"oldNameTitle":271,"oldOrganization":271},"Zhimin Shao","Professor","100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012",false,"NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.","FEMALE","18 Years","70 Years",{"count":438,"type":439},716,"ESTIMATED","INTERVENTIONAL",[442],"PHASE2","The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[445,446,447,448,449,450,451,452,453,454],"Breast Neoplasm","Breast Cancer","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-22",{"date":457,"type":458},"2026-05-28","ACTUAL",{"date":460,"type":458},"2022-11-01",{"date":462,"type":439},"2029-09",{"name":5,"class":6},1]