[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100406724":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":47,"centralContacts":52,"locations":60,"responsibleParty":76,"collaborators":78,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":40,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":40,"studyType":103,"phases":104,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":62,"whyStopped":40,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"epirubicin\u002FCTX × 4 - docetaxel × 4, every 3 weeks a cycle","ACTIVE_COMPARATOR","Cycle 1-4: Epirubicin i.v. 90 mg\u002Fm2, Cyclophosphamide i.v. 600 mg\u002Fm2 (One cycle = 21 days); Cycle 5-8: Docetaxel i.v. 100mg\u002Fm2 (One cycle = 21 days) .",[13,14,15],"Drug: Epirubicin","Drug: Cyclophosphamid","Drug: Docetaxel",{"label":17,"type":18,"description":19,"interventionNames":20},"epirubicin\u002FCTX × 4 - paclitaxel × 4, every 2 weeks a cycle","EXPERIMENTAL","Cycle 1-4: Epirubicin i.v. 90 mg\u002Fm2, Cyclophosphamide i.v. 600 mg\u002Fm2 (One cycle = 14 days); Cycle 5-8:Paclitaxel i.v. 175mg\u002Fm2 (One cycle = 14 days) .",[13,14,21],"Drug: Paclitaxel",[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Epirubicin","i.v. 90 mg\u002Fm2",[9,17],[29],"Epirubicin Hydrochloride",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Cyclophosphamid","i.v. 600 mg\u002Fm2",[9,17],[35],"CTX",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Docetaxel","i.v. 100 mg\u002Fm2",[9],null,{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Paclitaxel","i.v. 175 mg\u002Fm2",[17],[46],"PTX",[48],{"name":49,"affiliation":50,"role":51},"Yiding Chen","2nd Affiliated Hospital, School of Medicine, Zhejiang University","PRINCIPAL_INVESTIGATOR",[53,57],{"name":49,"role":54,"phone":55,"phoneExt":40,"email":56},"CONTACT","571-87784527","ydchen@zju.edu.cn",{"name":58,"role":54,"phone":55,"phoneExt":40,"email":59},"Huihui Chen","huihuicyj@zju.edu.cn",[61],{"facility":50,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":69,"coordinates":70},"Point",[71,72],120.16142,30.29365,{"lat":72,"lon":71},[75],{"name":49,"role":54,"phone":55,"phoneExt":40,"email":56},{"type":77,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[79,81,83,85,88],{"name":80,"class":6},"Women's Hospital School Of Medicine Zhejiang University",{"name":82,"class":6},"Changxing People's Hospital",{"name":84,"class":6},"Zhejiang Provincial People's Hospital",{"name":86,"class":87},"Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry","UNKNOWN",{"name":89,"class":6},"Huizhou Municipal Central Hospital","100406724","phase-2-efficacy-and-safety-of-dose-dense-chemotherapy-ddec-ddp-for-neoadjuvant-chemotherapy-of-her2-negative-breast-cancer-100406724",false,"NCT04576143","Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer","Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer：a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Female aged 18-70 years old;\n2. Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable), clinical stage IIA-IIIA;\n3. Definite reports on ER\u002FPR\u002FHER2 receptor showing all HER2 negative (HER2 is 0\\~1+ or 2+ but determined negative via fluorescence in situ hybridization (FISH) or chemiluminescent in situ hybridization (CISH) detected (no amplification) is defined as HER2 negative);\n4. According to RECIST 1.1, there is at least one measurable objective focus, tumor size \\> 2cm;\n5. Eastern Cooperative Oncology Group (ECOG) performance score is 0 or 1;\n6. Cardiac function: left ventricular ejection fraction (LVEF)≥55%;\n7. Normal bone marrow function: White blood cell count \\> 4 × 10\\^9\u002Fl, neutrophil count \\> 1.5 × 10\\^9\u002Fl, platelet count \\> 100 × 10\\^9\u002Fl and hemoglobin 9g\u002Fdl;\n8. Normal liver and renal function: aspartate aminotransferase (AST) and ALT ≤2.5 folds of the upper limit of normal values, total bilirubin ≤1.5 folds of the upper limit of normal values; Serum creatinine ≤1.5 folds of the upper limit of normal value.\n9. Informed consent form signed.\n\nExclusion Criteria:\n\n1. HER2 is positive;\n2. Metastasis at any location;\n3. Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;\n4. Severe systemic disease and\u002For uncontrollable infection, unable to be enrolled in this study;\n5. Known allergic or intolerable to chemotherapeutic agents;\n6. Previously suffering from malignant tumors within 5 years (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;\n7. Cardiovascular disease: LVEF \\\u003C50% (echocardiography) of New York Heart Association (NYHA) ≥ grade 2;\n8. Pregnant and breast-feeding women; Pregnancy test showed positive results before drug administration after enrolling in to the study; Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;\n9. Already enrolled into other clinical trials;\n10. The researchers judged the patients who were not suitable for this study.","FEMALE","18 Years","70 Years",{"count":101,"type":102},260,"ESTIMATED","INTERVENTIONAL",[105,106],"PHASE2","PHASE3","Recent clinical studies showed that breast cancer patients especially for those with lymph node metastasis may benefit from dose-dense chemotherapy, like adriamycin and cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd) regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative breast cancer patients. In our study, a prospective, randomized, open-label, multi-center clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy regimen (dd epirubicin\u002Fcyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional chemotherapy (epirubicin\u002Fcyclophosphamide (EC) followed by docetaxel (T)) as preoperative neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese population.",[109,110],"HER2-negative Breast Cancer","Neoadjuvant Chemotherapy",[112,113,114,115,116],"HER2-negative breast cancer","dose-dense chemotherapy","preoperative neoadjuvant chemotherapy","EC-T","ddEC-ddP","2021-08-09",{"date":119,"type":120},"2021-08-12","ACTUAL",{"date":122,"type":120},"2020-09-20",{"date":124,"type":102},"2027-09-20",{"name":5,"class":6},1]