[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585306":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":83,"collaborators":41,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":41,"enrollmentInfo":96,"targetDuration":41,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":68,"whyStopped":41,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose level 1","EXPERIMENTAL","In this dose level, all subjects will receive a dose of 1.3m\u002Fm2 bortezomib combined with a dose of 50mg\u002Fm2 cisplatin.",[13,14],"Drug: Bortezomib (B)","Drug: Cisplatin (CDDP)",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose level 2","In this dose level, all subjects will receive a dose of 1.5m\u002Fm2 bortezomib combined with a dose of 50mg\u002Fm2 cisplatin.",[14,13],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose level 3","In this dose level, all subjects will receive a dose of 1.7m\u002Fm2 bortezomib combined with a dose of 50mg\u002Fm2 cisplatin.",[14,13],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose level 4","In this dose level, all subjects will receive a dose of 1.3m\u002Fm2 bortezomib combined with a dose of 75mg\u002Fm2 cisplatin.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Dose level 5","In this dose level, all subjects will receive a dose of 1.5m\u002Fm2 bortezomib combined with a dose of 75mg\u002Fm2 cisplatin.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Dose level 6","In this dose level, all subjects will receive a dose of 1.7m\u002Fm2 bortezomib combined with a dose of 75mg\u002Fm2 cisplatin.",[13,14],[36,42,46,49,52],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Bortezomib (B)","1.3mg\u002Fm2, IV, D1, D4, D8 and D11, every 3 weeks",[9,24],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Cisplatin (CDDP)","50mg\u002Fm2, IV, D1-3, every 3 weeks",[9,16,20],{"type":37,"name":38,"description":47,"armGroupLabels":48,"otherNames":41},"1.5mg\u002Fm2, IV, D1, D4, D8 and D11, every 3 weeks",[16,28],{"type":37,"name":38,"description":50,"armGroupLabels":51,"otherNames":41},"1.7mg\u002Fm2, IV, D1, D4, D8 and D11, every 3 weeks",[20,32],{"type":37,"name":43,"description":53,"armGroupLabels":54,"otherNames":41},"70mg\u002Fm2, IV, D1-3, every 3 weeks",[24,28,32],[56],{"name":57,"affiliation":5,"role":58},"Yan-xia Shi, Doctor","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":41,"email":64},"Yanxia Shi, Doctor","CONTACT","86-020-87343486","shiyx@sysucc.org.cn",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Sun Yat-Sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":75,"coordinates":76},"Point",[77,78],113.25,23.11667,{"lat":78,"lon":77},[81,82],{"name":61,"role":62,"phone":63,"phoneExt":41,"email":64},{"name":61,"role":58,"phone":41,"phoneExt":41,"email":41},{"type":58,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Shi Yanxia","Professor","100585306","phase-1-bortezomib-plus-cisplatin-in-recurrent-or-metastatic-breast-cancer-100585306",false,"NCT06900647","Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer","Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer","BOCIS","Inclusion Criteria:\n\n1. Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;\n2. The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);\n3. Patients who have failed standard treatment in the late stage;\n4. At least one measurable lesion;\n5. ECOG PS : 0-2 points;\n6. Estimated survival period ≥12 weeks;\n7. The function level of major organs meets the following standards:\n\n1\\) The blood routine examination standards must meet: ANC ≥1.5×109\u002FL, PLT ≥75×109\u002FL, Hb ≥85g\u002FL (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction) 2) Biochemical examinations must meet the following standards: TBIL \\\u003C1.5×ULN, ALT, AST \\\u003C2.5×ULN, ALT, AST \\\u003C5×ULN for patients with liver metastasis, BUN and Cr ≤1×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug.\n\n9\\. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\nAny of the following will be considered as meeting the exclusion criteria of the study:\n\n1. Patients with acute active hepatitis B or acute active hepatitis C;\n2. Any serious underlying disease, comorbidity and active infection\n3. Currently receiving other anti-tumor treatments;\n4. History of epilepsy or epileptic-induced condition;\n5. Patients who are pregnant or breastfeeding;\n6. Those with poor compliance or unable to undergo normal follow-up;\n7. Allergic to study drugs;\n8. Patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal carcinoma in situ, or malignant tumors diagnosed 2 years ago with no current evidence of disease and untreated ≤ 2 years before randomization;\n9. The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.","FEMALE","18 Years",{"count":97,"type":98},20,"ESTIMATED","INTERVENTIONAL",[101],"PHASE1","This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.",[104,105],"Metastatic Breast Cancer","Recurrent Breast Cancer",[107,108,109],"Breast cancer","Bortezomib","Cisplatin","2025-03-27",{"date":112,"type":113},"2025-04-02","ACTUAL",{"date":115,"type":113},"2025-01-01",{"date":117,"type":98},"2028-06-30",{"name":5,"class":6},1]