[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461335":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":56,"locations":66,"responsibleParty":80,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":31,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":31,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":31,"overallStatus":108,"whyStopped":31,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},{"fullName":5,"class":6},"ChineseAMS","UNKNOWN",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"AC followed by albumin-bound paclitaxel","EXPERIMENTAL","A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.",[13,14,15,16,17],"Drug: doxorubicin","Drug: epirubicin","Drug: pirarubicin","Drug: cyclophosphamide","Drug: albumin-bound paclitaxel",{"label":19,"type":20,"description":21,"interventionNames":22},"AC followed by taxanes","ACTIVE_COMPARATOR","A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.",[13,14,15,16,23,24],"Drug: paclitaxel","Drug: docetaxel",[26,32,36,40,44,48,52],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","doxorubicin","doxorubicin 50\\~60mg\u002Fm2, i.v., d1, q3w or q2w.",[9,19],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"epirubicin","epirubicin 80\\~100mg\u002Fm2, i.v., d1, q3w or q2w.",[9,19],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"pirarubicin","pirarubicin 40\\~50mg\u002Fm2, i.v., d1, q3w or q2w.",[9,19],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"cyclophosphamide","cyclophosphamide 600mg\u002Fm2, i.v., d1, q3w or q2w.",[9,19],{"type":27,"name":45,"description":46,"armGroupLabels":47,"otherNames":31},"albumin-bound paclitaxel","albumin-bound paclitaxel 260mg\u002Fm2, i.v., d1, q3w; 260mg\u002Fm2, i.v., d1, q2w; or 125mg\u002Fm2, i.v., d1, qw.",[9],{"type":27,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"paclitaxel","paclitaxel 175mg\u002Fm2, i.v., d1, q3w; 175mg\u002Fm2, i.v., d1, q2w; or 80mg\u002Fm2, i.v., d1, qw.",[19],{"type":27,"name":53,"description":54,"armGroupLabels":55,"otherNames":31},"docetaxel","docetaxel 80\\~100mg\u002Fm2, i.v., d1, q3w.",[19],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":31,"email":61},"Qiao Li, MD","CONTACT","86-10-87788120","liqiaopumc@yahoo.cn",{"name":63,"role":59,"phone":64,"phoneExt":31,"email":65},"Binghe Xu, PHD","86-10-87788495","xubinghe@medmail.com.cn",[67],{"facility":68,"status":31,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":31},"Cancer Hospital, ChineseAMS","Beijing","Beijing Municipality","100021","China","CN",{"type":75,"coordinates":76},"Point",[77,78],116.39723,39.9075,{"lat":78,"lon":77},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":84,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Binghe Xu","Academician，Director of Department of Clinical Trial Center","Chinese Academy of Medical Sciences",[86],{"name":87,"class":88},"CSPC Ouyi Pharmaceutical Co., Ltd.","INDUSTRY","100461335","adjuvant-albumin-bound-paclitaxel-versus-taxanes-in-breast-cancer-a-real-world-study-100461335",false,"NCT05287308","Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study","Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study","Inclusion Criteria:\n\n1. Female patients aged from 18 to 70 years old;\n2. Histologically confirmed as invasive breast cancer;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;\n5. AC-T adjuvant chemotherapy is planned after breast cancer surgery;\n6. Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence \\[such as high Ki67 expression (≥20%), T \\> 2 cm, age \\\u003C 35 years, lymphovascular invasion, grade 3 histology\\]; 2) HR negative with positive lymph node or T \\> 2 cm;\n7. LVEF ≥ 50%;\n8. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.\n\nExclusion Criteria:\n\n1. In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \\> 100\u002Fmin in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \\[Mobitz 2\\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure \\> 180mm Hg or diastolic blood pressure \\> 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;\n2. Participants who have received prior any systematic treatment for breast cancer;\n3. Participants with bilateral invasive breast cancer;\n4. Breast cancer with distant metastasis;\n5. Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;\n6. Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active peptic ulcer, unstable diabetes;\n7. Previous or current existence of other malignant tumors other than breast cancer;\n8. Severe liver and kidney dysfunction;\n9. The presence of any myelodysplastic and other hematopoietic disorders;\n10. Participants who are known to be allergic to the active or other components of the study treatment;\n11. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;\n12. Participants who were judged by the investigator to be unsuitable for this study.","FEMALE","18 Years","70 Years",{"count":100,"type":101},500,"ESTIMATED","INTERVENTIONAL",[104],"NA","This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.",[107],"Breast Cancer","NOT_YET_RECRUITING","2022-03-17",{"date":111,"type":112},"2022-03-31","ACTUAL",{"date":114,"type":101},"2022-03",{"date":116,"type":101},"2027-09",{"name":84,"class":118},"OTHER",1]