[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584629":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":56,"overallOfficials":33,"centralContacts":74,"locations":80,"responsibleParty":416,"collaborators":418,"id":421,"slug":422,"hasResults":423,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":33,"eligibilityCriteria":427,"healthyVolunteers":423,"sex":428,"minAge":429,"maxAge":430,"enrollmentInfo":431,"targetDuration":33,"studyType":434,"phases":435,"briefSummary":438,"conditions":439,"keywords":33,"overallStatus":341,"whyStopped":33,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological complete response (pCR) rate","Pathological complete response (pCR) rate will be investigated.","Up to approximately 48 months",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Event-free survival (EFS)","Event-free survival (EFS) is defined as the time between the day the subject is randomized and the first occurrence of any event.",{"measure":18,"description":19,"timeFrame":12},"Invasive disease-free survival (IDFS)","Invasive disease-free survival (IDFS) is defined as the time interval from the date of radical surgery to the presence of ipsilateral or contralateral recurrence of invasive breast cancer, locoregional recurrence, distant recurrence, or death from any cause, whichever occurs first.",{"measure":21,"description":22,"timeFrame":12},"Overall Survival (OS)","Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.",{"measure":24,"description":25,"timeFrame":12},"Treatment Emergent Adverse Event (TEAE)","TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and\u002For intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.",{"measure":27,"description":28,"timeFrame":12},"Pathologic complete response (pCR) rate as assessed by the pathologists","Pathologic complete response (pCR) rate as assessed by the pathologists at the participating study centers will be investigated.",{"measure":30,"description":31,"timeFrame":32},"Objective Response Rate (ORR)","Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).","Up to approximately 24 months",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41,48],{"label":42,"type":43,"description":44,"interventionNames":45},"Study treatment","EXPERIMENTAL","Participants receive BL-M07D1 with or without Pertuzumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[46,47],"Drug: BL-M07D1","Drug: Pertuzumab",{"label":49,"type":50,"description":51,"interventionNames":52},"docetaxel + carboplatin + trastuzumab + pertuzumab","ACTIVE_COMPARATOR","Participants receive docetaxel + carboplatin + trastuzumab + pertuzumaby in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[47,53,54,55],"Drug: docetaxel","Drug: carboplatin","Drug: trastuzumab",[57,62,65,68,71],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"DRUG","BL-M07D1","Administration by intravenous infusion for a cycle of 3 weeks.",[42],{"type":58,"name":63,"description":60,"armGroupLabels":64,"otherNames":33},"Pertuzumab",[42,49],{"type":58,"name":66,"description":60,"armGroupLabels":67,"otherNames":33},"docetaxel",[49],{"type":58,"name":69,"description":60,"armGroupLabels":70,"otherNames":33},"carboplatin",[49],{"type":58,"name":72,"description":60,"armGroupLabels":73,"otherNames":33},"trastuzumab",[49],[75],{"name":76,"role":77,"phone":78,"phoneExt":33,"email":79},"Sa Xiao, 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Pan",{"facility":109,"status":83,"city":99,"state":85,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)",{"type":89,"coordinates":111},[102,103],{"lat":103,"lon":102},[114],{"name":115,"role":77,"phone":33,"phoneExt":33,"email":33},"Xiaopeng Ma",{"facility":117,"status":83,"city":118,"state":119,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality",{"type":89,"coordinates":121},[122,123],106.55771,29.56026,{"lat":123,"lon":122},[126],{"name":127,"role":77,"phone":33,"phoneExt":33,"email":33},"Qiao Cheng",{"facility":129,"status":83,"city":130,"state":131,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Fujian Medical University Union Hospital","Fuzhou","Fujian",{"type":89,"coordinates":133},[134,135],119.30611,26.06139,{"lat":135,"lon":134},[138],{"name":139,"role":77,"phone":33,"phoneExt":33,"email":33},"Chuan Wang",{"facility":141,"status":83,"city":142,"state":143,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Guangdong Maternal and Child Health Center","Guangzhou","Guangdong",{"type":89,"coordinates":145},[146,147],113.25,23.11667,{"lat":147,"lon":146},[150],{"name":151,"role":77,"phone":33,"phoneExt":33,"email":33},"Antai Zhang",{"facility":153,"status":83,"city":142,"state":143,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University",{"type":89,"coordinates":155},[146,147],{"lat":147,"lon":146},[158],{"name":159,"role":77,"phone":33,"phoneExt":33,"email":33},"Qiang Liu",{"facility":161,"status":83,"city":162,"state":143,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center","Shenzhen",{"type":89,"coordinates":164},[165,166],114.0683,22.54554,{"lat":166,"lon":165},[169],{"name":170,"role":77,"phone":33,"phoneExt":33,"email":33},"Jidong Gao",{"facility":172,"status":83,"city":173,"state":174,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Liuzhou People's Hospital","Liuzhou","Guangxi",{"type":89,"coordinates":176},[177,178],109.40698,24.32405,{"lat":178,"lon":177},[181],{"name":182,"role":77,"phone":33,"phoneExt":33,"email":33},"Junyang Mo",{"facility":184,"status":83,"city":185,"state":174,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Guangxi Medical University Cancer Hospital","Nanning",{"type":89,"coordinates":187},[188,189],108.31667,22.81667,{"lat":189,"lon":188},[192],{"name":193,"role":77,"phone":33,"phoneExt":33,"email":33},"Huawei Yang",{"facility":195,"status":83,"city":196,"state":197,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Hainan General Hospital","Haikou","Hainan",{"type":89,"coordinates":199},[200,201],110.34651,20.03421,{"lat":201,"lon":200},[204],{"name":205,"role":77,"phone":33,"phoneExt":33,"email":33},"Ru Chen",{"facility":207,"status":83,"city":208,"state":209,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"The Fourth Hospital of Hebei Medical University","Shijiazhuang","Hebei",{"type":89,"coordinates":211},[212,213],114.47861,38.04139,{"lat":213,"lon":212},[216],{"name":217,"role":77,"phone":33,"phoneExt":33,"email":33},"Yunjiang Liu",{"facility":219,"status":83,"city":220,"state":209,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Xingtai People's Hospital","Xingtai",{"type":89,"coordinates":222},[223,224],114.49272,37.06217,{"lat":224,"lon":223},[227],{"name":228,"role":77,"phone":33,"phoneExt":33,"email":33},"Xiangshun Kong",{"facility":230,"status":83,"city":231,"state":232,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang",{"type":89,"coordinates":234},[235,236],126.65,45.75,{"lat":236,"lon":235},[239],{"name":240,"role":77,"phone":33,"phoneExt":33,"email":33},"Tong Liu",{"facility":242,"status":83,"city":243,"state":244,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Anyang Cancer Hospital","Anyang","Henan",{"type":89,"coordinates":246},[247,248],114.38278,36.096,{"lat":248,"lon":247},[251],{"name":252,"role":77,"phone":33,"phoneExt":33,"email":33},"Ya Wei",{"facility":254,"status":83,"city":255,"state":244,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"The First Affiliated Hospital of Henan University of science and technology","Luoyang",{"type":89,"coordinates":257},[258,259],112.43684,34.67345,{"lat":259,"lon":258},[262],{"name":263,"role":77,"phone":33,"phoneExt":33,"email":33},"Xinshuai Wang",{"facility":265,"status":83,"city":266,"state":244,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Henan Provincial People's Hospital","Zhengzhou",{"type":89,"coordinates":268},[269,270],113.64861,34.75778,{"lat":270,"lon":269},[273],{"name":274,"role":77,"phone":33,"phoneExt":33,"email":33},"Hui Liu",{"facility":276,"status":83,"city":277,"state":278,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Hunan Cancer Hospital","Changsha","Hunan",{"type":89,"coordinates":280},[281,282],112.97087,28.19874,{"lat":282,"lon":281},[285],{"name":286,"role":77,"phone":33,"phoneExt":33,"email":33},"Xiaobo Hu",{"facility":288,"status":83,"city":277,"state":278,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":289,"geoPoint":291,"contacts":292},"The Second Xiangya Hospital of Central South University",{"type":89,"coordinates":290},[281,282],{"lat":282,"lon":281},[293],{"name":294,"role":77,"phone":33,"phoneExt":33,"email":33},"Wenjun Yi",{"facility":296,"status":83,"city":297,"state":298,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":89,"coordinates":300},[301,302],115.85306,28.68396,{"lat":302,"lon":301},[305],{"name":306,"role":77,"phone":33,"phoneExt":33,"email":33},"Yingliang Li",{"facility":308,"status":83,"city":309,"state":310,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"Shaanxi Provincial People's Hospital","Xi'an","Shaanxi",{"type":89,"coordinates":312},[313,314],108.92861,34.25833,{"lat":314,"lon":313},[317],{"name":318,"role":77,"phone":33,"phoneExt":33,"email":33},"Jianhui Li",{"facility":320,"status":83,"city":309,"state":310,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":321,"geoPoint":323,"contacts":324},"The First Affiliated Hospital of Xi'an Jiaotong University",{"type":89,"coordinates":322},[313,314],{"lat":314,"lon":313},[325],{"name":326,"role":77,"phone":33,"phoneExt":33,"email":33},"Yu Ren",{"facility":328,"status":83,"city":329,"state":330,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Shandong Cancer Hospital","Jinan","Shandong",{"type":89,"coordinates":332},[333,334],116.99722,36.66833,{"lat":334,"lon":333},[337],{"name":338,"role":77,"phone":33,"phoneExt":33,"email":33},"Yongsheng Wang",{"facility":340,"status":341,"city":342,"state":343,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality",{"type":89,"coordinates":345},[346,347],121.45806,31.22222,{"lat":347,"lon":346},[350],{"name":351,"role":77,"phone":33,"phoneExt":33,"email":33},"Zhimin Shao",{"facility":353,"status":83,"city":354,"state":355,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Shanxi Bethune Hospital","Taiyuan","Shanxi",{"type":89,"coordinates":357},[358,359],112.56028,37.86944,{"lat":359,"lon":358},[362],{"name":363,"role":77,"phone":33,"phoneExt":33,"email":33},"Xiaojun Zhang",{"facility":365,"status":83,"city":354,"state":355,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":366,"geoPoint":368,"contacts":369},"Shanxi Cancer Hospital",{"type":89,"coordinates":367},[358,359],{"lat":359,"lon":358},[370],{"name":371,"role":77,"phone":33,"phoneExt":33,"email":33},"Guohui Han",{"facility":373,"status":83,"city":374,"state":375,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"Sichuan Cancer Hospital","Chengdu","Sichuan",{"type":89,"coordinates":377},[378,379],104.06667,30.66667,{"lat":379,"lon":378},[382],{"name":383,"role":77,"phone":33,"phoneExt":33,"email":33},"Junjie Li",{"facility":385,"status":83,"city":386,"state":387,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"Tianjin Cancer Hospital","Tianjin","Tianjin Municipality",{"type":89,"coordinates":389},[390,391],117.17667,39.14222,{"lat":391,"lon":390},[394],{"name":395,"role":77,"phone":33,"phoneExt":33,"email":33},"Jin Zhang",{"facility":397,"status":83,"city":398,"state":399,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":89,"coordinates":401},[402,403],120.16142,30.29365,{"lat":403,"lon":402},[406],{"name":407,"role":77,"phone":33,"phoneExt":33,"email":33},"Peifen Fu",{"facility":409,"status":83,"city":398,"state":399,"zip":33,"country":86,"countryCode":87,"cosmosGeoPoint":410,"geoPoint":412,"contacts":413},"Zhejiang Cancer Hospital",{"type":89,"coordinates":411},[402,403],{"lat":403,"lon":402},[414],{"name":415,"role":77,"phone":33,"phoneExt":33,"email":33},"Yang Yu",{"type":417,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[419],{"name":420,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100584629","phase-2-a-study-of-bl-m07d1-with-or-without-pertuzumab-versus-taxane--trastuzumab-and-pertuzumab-in-neoadjuvant-therapy-for-her2-positive-breast-cancer-100584629",false,"NCT06891833","A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer","A Randomized Controlled Phase II\u002FIII Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily signed informed consent and followed the program requirements;\n2. Females ≥18 and ≤75 years of age at the time of signing the informed consent;\n3. Expected survival time ≥6 months;\n4. Patients with HER2-positive invasive breast cancer confirmed by histologic examination;\n5. Clear hormone receptor (HR) status;\n6. Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy;\n7. Primary subjects without antitumor therapy for breast cancer;\n8. Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy;\n9. Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart;\n10. Physical status score ECOG 0 or 1;\n11. Organ function levels must be met provided that blood transfusions are not permitted within 14 days prior to the first administration of study drug, colony-stimulating factors are not permitted, and so on;\n12. For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all enrolled patients should be using adequate and highly effective contraception throughout the treatment cycle and for 7 months after completion of treatment.\n\nExclusion Criteria:\n\n1. Diagnosis of stage IV metastatic breast cancer;\n2. Bilateral breast cancer;\n3. Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS);\n4. Diagnosis of another primary malignancy within 5 years prior to first dose;\n5. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;\n6. Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, and frequent and uncontrollable arrhythmias;\n7. Poorly controlled hypertension (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n8. Complicated lung disease resulting in severely impaired lung function;\n9. History of ILD \u002F interstitial pneumonitis requiring steroid hormone therapy, current ILD \u002F interstitial pneumonitis, or suspected of having such a disease, etc;\n10. Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;\n11. Severe infection within 4 weeks prior to first dose of study drug; active pulmonary inflammation present at screening;\n12. Ongoing treatment with \\>10 mg\u002Fd prednisone systemic corticosteroid therapy or equivalent anti-inflammatory active drug or any form of immunosuppressive therapy within 2 weeks prior to the first dose;\n13. Known hypersensitivity to the study therapeutic drug or any study drug excipients or other monoclonal antibodies;\n14. Patients who are not suitable to receive the investigational drug (paclitaxel, patulizumab, trastuzumab);\n15. Have a history of autologous or allogeneic stem cell transplantation or organ transplantation;\n16. Suffering from severe neurological or psychiatric disorders;\n17. Subjects with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to signing the information;\n18. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;\n19. Subjects who are scheduled to receive a live vaccine or who have received a live vaccine within 28 days prior to the first dose;\n20. Presence of other serious physical, laboratory test abnormalities or poor compliance that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.","FEMALE","18 Years","75 Years",{"count":432,"type":433},985,"ESTIMATED","INTERVENTIONAL",[436,437],"PHASE2","PHASE3","This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).",[440],"HER2-positive Breast Cancer","2026-08-24",{"date":443,"type":444},"2026-08-26","ACTUAL",{"date":446,"type":444},"2025-06-05",{"date":448,"type":433},"2028-12",{"name":5,"class":6},30]