[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372255":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":49,"centralContacts":32,"locations":32,"responsibleParty":53,"collaborators":32,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":32,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":32,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":32,"overallStatus":75,"whyStopped":32,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":32},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"TC*6","EXPERIMENTAL","6 cycles of (Docetaxel 75mg\u002Fm2 ivgtt d1+ Cyclophosphamide 600 mg\u002Fm2 iv d1, 21 days per cycle) .",[13,14],"Drug: Docetaxel","Drug: Cyclophosphamide",{"label":16,"type":10,"description":17,"interventionNames":18},"CEF*3-T*3","3 cycles of CEF (Epirubicin 100 mg\u002Fm2 ivgtt d1+Cyclophosphamide 500 mg\u002Fm2 iv d1+ 5-fluorouracil 500 mg\u002Fm2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg\u002Fm2, ivgtt d1, 21 days per cycle)",[13,14,19,20],"Drug: Epirubicin","Drug: 5-fluorouracil",{"label":22,"type":10,"description":23,"interventionNames":24},"EC*4-wP*12","4 cycles of EC (Epirubicin 90 mg\u002Fm2 ivgtt d1+Cyclophosphamide 600 mg\u002Fm2 iv d1, 21 days per cycle) followed by 4 cycles of Paclitaxel (Paclitaxel 80mg\u002Fm2, ivgtt d1,8,15, 21days per cycle).",[25,14,19],"Drug: Paclitaxel",[27,33,37,41,45],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Paclitaxel","Paclitaxel chemotherapy (injection)",[22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Docetaxel","Docetaxel chemotherapy (injection)",[16,9],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Cyclophosphamide","Cyclophosphamide chemotherapy (injection)",[16,22,9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Epirubicin","Epirubicin chemotherapy (injection)",[16,22],{"type":28,"name":46,"description":47,"armGroupLabels":48,"otherNames":32},"5-fluorouracil","5-fluorouracil chemotherapy (injection)",[16],[50],{"name":51,"affiliation":5,"role":52},"Zhi-Ming Shao","PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Zhimin Shao","professor","100372255","phase-3-adjuvant-6-cycles-of-docetaxel-and-cyclophosphamide-or-3-cycles-of-cyclophosphamideepirubicinfluorouracil-followed-by-3-cycles-of-docetaxel-versus-4-cycles-of-epirubicin-and-cyclophosphamide-followed-by-weekly-paclitaxel-in-operable-breast-cancer-master-100372255",false,"NCT04127019","Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide\u002FEpirubicin\u002FFluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer (MASTER)","Adjuvant Six Cycles of Docetaxel and Cyclophosphamide or Three Cycles of Cyclophosphamide\u002FEpirubicin\u002FFluorouracil Followed by Three Cycles of Docetaxel Versus Four Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer","Inclusion Criteria:\n\n* Female patients, age at diagnosis 18 - 75 years\n* Histological confirmed unilateral primary invasive carcinoma of the breast\n* Adequate surgical treatment with complete resection of the tumor (R0) and resection of \\> or = 10 axillary nodes or SLN in clinically N0 patients\n* Node positive disease or node negative disease with at least one other risk factor (tumor size \\> or = 2 cm, grade \\> or = II)\n* No evidence for distant metastasis (M0) after conventional staging\n* Performance Status ECOG \\\u003C or = 1\n* The patient must be accessible for treatment and follow-up\n* LVEF\\> 50%\n* Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients\n* Leucocytes \\> or = 4 x 10\\^9\u002FL\n* platelets \\> or = 100 x 10\\^9\u002FL\n* haemoglobin \\> or = 9 g\u002FdL\n* total bilirubin \\\u003C or = 1.5 UNL\n* ASAT (SGOT) and ALAT (SGPT) \\\u003C or = 2.5 UNL\n* creatinine \\\u003C 175 mmol\u002FL (2 mg\u002FdL)\n\nExclusion Criteria:\n\n1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;\n2. Has bilateral breast cancer;\n3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.\n4. Has metastic (Stage 4) breast cancer;\n5. Has any \\>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);\n6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;\n7. Patients participating in other clinical trials at the same time;\n8. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \\\u003C 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\\>150\u002F90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;\n9. Has known allergy to taxane and excipients;\n10. Has severe or uncontrolled infection.","FEMALE","18 Years","75 Years",{"count":67,"type":68},2079,"ACTUAL","INTERVENTIONAL",[71],"PHASE3","We aimed to evaluate the noninferiority of a short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or a short-term anthracycline-based chemotherapy (CEF-T, three cycles of cyclophosphamide\u002Fepirubicin\u002Ffluorouracil followed by three cycles of docetaxel) to a standard anthracycline\u002Ftaxane-containing chemotherapy (EC-P, epirubicin and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in operable breast cancer.",[74],"Primary Breast Cancer","COMPLETED","2020-02-23",{"date":78,"type":68},"2020-02-26",{"date":80,"type":68},"2010-06-01",{"date":82,"type":68},"2017-06-15",{"name":5,"class":6}]