[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495214":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":19,"responsibleParty":39,"collaborators":43,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":21,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Shantou Central Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"dose-dense arm","EXPERIMENTAL",null,[13],"Drug: dose-dense nab-paclitaxel followed by EC",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","dose-dense nab-paclitaxel followed by EC",[9],[20],{"facility":5,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"RECRUITING","Shantou","Guangdong","510000","China","CN",{"type":28,"coordinates":29},"Point",[30,31],116.67876,23.35489,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Haitong Lyu","CONTACT","+8613631403739","heton25@foxmali.com",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Zhiyong Wu","Dr.",[44,46],{"name":45,"class":6},"Shantou University Medical College",{"name":47,"class":6},"Jieyang People's Hospital","100495214","phase-2-neoadjuvant-dose-dense-chemotherapy-for-hrher2--breast-cancer-patients-with-high-proliferation-index-100495214",false,"NCT05728268","Neoadjuvant Dose-dense Chemotherapy for HR+\u002FHER2- Breast Cancer Patients With High Proliferation Index","Inclusion Criteria:\n\n* Females with age of 18 to 70 years old.\n* Newly diagnosed breast cancer patients.\n* Planned neoadjuvant chemotherapy.\n* Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.\n* HER2\u002Fneu-negative.\n* Ki67≥30%.\n* Clinical stage IIB-IIIC.\n* Informed consent form understood and signed.\n* Patient agrees to all follow-up visits.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Women of childbearing potential must have a negative serum pregnancy test.\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy.\n* Nursing mothers.\n* Active or uncontrolled infection.\n* Presence of another malignancies.\n* Granulocyte count \\\u003C 1.5\\*10\\^9\u002FL.\n* Platelet count \\\u003C 100\\*10\\^9\u002FL.\n* Hemoglobin \\\u003C 90g\u002FL.\n* Serum Creatinine more than 1.5 upper limit.\n* AST and ALT more than 2.5 upper limit.\n* LVEF\\\u003C 50%.","FEMALE","18 Years","70 Years",{"count":58,"type":59},64,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+\u002FHER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+\u002FHER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+\u002FHER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.",[65],"Breast Cancer","2025-12-28",{"date":68,"type":69},"2026-01-02","ACTUAL",{"date":71,"type":69},"2021-08-01",{"date":73,"type":59},"2025-12-30",{"name":5,"class":6},1]