[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497763":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":22,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":22,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":22,"overallStatus":45,"whyStopped":22,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"First Affiliated Hospital, Sun Yat-Sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Camrelizumab, Fluzoparib and Nab-paclitaxel","EXPERIMENTAL","Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.",[13,14,15],"Drug: Camrelizumab","Drug: Fluzoparib","Drug: Nab-paclitaxel",[17,23,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Camrelizumab","Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle.\n\nFluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.",[9],null,{"type":18,"name":24,"description":24,"armGroupLabels":25,"otherNames":22},"Fluzoparib",[9],{"type":18,"name":27,"description":27,"armGroupLabels":28,"otherNames":22},"Nab-paclitaxel",[9],[30],{"name":31,"affiliation":32,"role":33},"Ying Lin, MD","Principal Investigator","STUDY_CHAIR",[35,40],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","+8602087755766","8212","linying3@mail.sysu.edu.cn",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},"Xiaying Kuang, MD","kuangxy5@mail.sysu.edu.cn",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Ying Lin","director of department","100497763","phase-2-neoadjuvant-camrelizumab-and-fluzoparib-and-nab-paclitaxel-in-early-breast-cancer-with-hrr-gene-mutation-100497763",false,"NCT05761470","Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation","A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation","IMPARP","Inclusion Criteria:\n\n* Histologically documented Her-2 negative\n* TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3\n* No distant metastatic disease\n* Eastern Cooperative Oncology Group Performance Status: 0\\~1\n* HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating at the time of randomization or refuse to contraception.\n* Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ\n* Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.\n* Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.\n* Patients who have used immunosuppressive drug or corticosteroids within 14 days.\n* Patients who have other diseases which researchers.\n* Patients who allergy to any of the drugs in this trail.","ALL","18 Years","75 Years",{"count":75,"type":76},66,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.",[82,83],"Her-2 Negative Breast Cancer","HRR Gene Mutation","2023-03-07",{"date":86,"type":87},"2023-03-09","ACTUAL",{"date":89,"type":87},"2022-05-06",{"date":91,"type":76},"2028-12-31",{"name":61,"class":6},1]