[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-negative-advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-negative-advanced-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100654902","phase-3-a-study-of-hb1801-versus-docetaxel-taxotere-in-patients-with-advanced-breast-cancer-100654902",false,"NCT07805135","A Study of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer","A Randomized, Open-Label, Multicenter Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age: 18-75 years (Whichever is on the day of signing the informed consent form).\n* 2\\. Subjects have histologically or cytologically confirmed breast cancer at unresectable，recurrent\u002Fmetastatic stage, with the requirements below based on the most recent pathological report:\n\n  1. HER2-negative confirmed by histological or cytological testing;\n  2. Pathological report is available to confirm HR status.\n* 3\\. Assessed by the Investigator as suitable for single-agent docetaxel therapy.\n* 4\\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n* 5\\. Has adequate organ and system functions within 7 days prior to the first dose.\n* 6\\. Eastern Cooperative Oncology Group performance status of 0 or 1.\n* 7\\. Expected survival ≥ 3 months.\n\nExclusion Criteria:\n\n* 1\\. Has received prior taxane-containing single-agent or combination regimens, and have disease progression during salvage therapy for unresectable locally advanced or metastatic breast cancer (has received at least 2 cycles), or developed recurrent-metastatic disease within 12 months following adjuvant therapy.\n* 2\\. History of severe allergy or hypersensitivity reactions (Grade ≥3 per NCI-CTCAE Version 6.0) to human serum albumin or docetaxel and\u002For contraindications thereto, or history of severe allergy and\u002For contraindications to glucocorticoids.\n* 3\\. Untreated active brain metastases (including brain or leptomeningeal metastases). Subjects with treated brain metastases may be enrolled if lesions are stable without evidence of new or enlarging pre-existing brain metastases.\n* 4\\. With a history of other primary malignant tumors within 5 years before administration.\n* 5\\. Presence of serous cavity effusion requiring drainage or diuretic therapy within 2 weeks prior to the first dose.\n* 6\\. Severe neurological diseases (e.g., epilepsy, dementia, etc.) and Grade ≥2 peripheral neuropathy.\n* 7\\. Receipt of systemic glucocorticoid therapy within 14 days prior to the first dose.\n* 8\\. Current clinically significant abnormal interstitial lung disease.\n* 9\\. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose.\n* 10\\. Has arterial or venous thromboembolism (e.g., lower-extremity deep vein thrombosis, lower-extremity arterial embolism, pulmonary embolism, etc.) within 6 months prior to the first dose. Stable thrombus is permitted for enrollment if the Investigator assesses no associated cardiovascular risk.\n* 11\\. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks prior to the first dose.\n* 12\\. Has undergone major visceral organ surgery (excluding puncture biopsy or infusion device implantation) within 4 weeks prior to the first dose, or who require major visceral organ surgery during the study period.\n* 13\\. Receipt of chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or other investigational study drug within 4 weeks or 5 half-lives prior to the first dose (whichever is shorter, with a minimum of 2 weeks); receipt of radiotherapy within 2 weeks prior to the first dose; receipt of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose.\n* 14\\. Toxicities from all prior anti-tumor therapies have not recovered to Grade 1 or less prior to the first dose.\n* 15\\. Has received powerful CYP3A4 inhibitor or inducer within 2 weeks before the first dose.\n* 16\\. Has active hepatitis B infection, hepatitis C infection, positive HIV antibody, or active syphilis.\n* 17\\. Concurrent participation in another interventional clinical study.\n* 18\\. Any other conditions that, in the Investigator's opinion, render the participant unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},430,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a randomized, open-label, multicenter Phase Ⅲ clinical trial designed to evaluate the efficacy and safety of HB1801 versus Taxotere® in patients with HER2-negative advanced breast cancer.",[27],"HER2-Negative Advanced Breast Cancer","NOT_YET_RECRUITING","2026-09-03",{"date":31,"type":32},"2026-09-04","ACTUAL",{"date":34,"type":21},"2026-08-31",{"date":36,"type":21},"2029-06-01",{"name":38,"class":39},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY"]