NCT07805135尚未招募3 期
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 个研究点目标入组 430 人开始时间: 2026年8月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age: 18-75 years (Whichever is on the day of signing the informed consent form).
- •2. Subjects have histologically or cytologically confirmed breast cancer at unresectable，recurrent/metastatic stage, with the requirements below based on the most recent pathological report:
- •HER2-negative confirmed by histological or cytological testing;
- •Pathological report is available to confirm HR status.
- •3. Assessed by the Investigator as suitable for single-agent docetaxel therapy.
- •4. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
- •5. Has adequate organ and system functions within 7 days prior to the first dose.
- •6. Eastern Cooperative Oncology Group performance status of 0 or
- •7. Expected survival ≥ 3 months.
排除标准
- •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.
- •2. History of severe allergy or hypersensitivity reactions (Grade ≥3 per NCI-CTCAE Version 6.0) to human serum albumin or docetaxel and/or contraindications thereto, or history of severe allergy and/or contraindications to glucocorticoids.
- •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.
- •4. With a history of other primary malignant tumors within 5 years before administration.
- •5. Presence of serous cavity effusion requiring drainage or diuretic therapy within 2 weeks prior to the first dose.
- •6. Severe neurological diseases (e.g., epilepsy, dementia, etc.) and Grade ≥2 peripheral neuropathy.
- •7. Receipt of systemic glucocorticoid therapy within 14 days prior to the first dose.
- •8. Current clinically significant abnormal interstitial lung disease.
- •9. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose.
- •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.
- •11. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks prior to the first dose.
- •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.
- •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.
- •14. Toxicities from all prior anti-tumor therapies have not recovered to Grade 1 or less prior to the first dose.
- •15. Has received powerful CYP3A4 inhibitor or inducer within 2 weeks before the first dose.
- •16. Has active hepatitis B infection, hepatitis C infection, positive HIV antibody, or active syphilis.
- •17. Concurrent participation in another interventional clinical study.
- •18. Any other conditions that, in the Investigator's opinion, render the participant unsuitable for participation in this clinical trial.
研究组 & 干预措施
HB1801
Experimental
干预措施: HB1801 (Drug)
Docetaxel (Taxotere®)
Experimental
干预措施: Docetaxel (Taxotere®) (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to approximately 2 years after the first enrollment
PFS was defined as the time from the date of randomization to the date of progressive disease (as per RECIST v1.1) or death due to any cause.
次要结局
- Objective Response Rate (ORR) assessed per RECIST v1.1(up to approximately 2 years after the first enrollment)
- Duration of Response (DOR)(up to approximately 2 years after the first enrollment)
- Disease Control Rate (DCR)(up to approximately 2 years after the first enrollment)
- Overall Survival (OS)(up to approximately 2 years after the first enrollment)
- The incidence and severity of adverse events (AE) and severe adverse events (SAE)(up to approximately 2 years after the first enrollment)
- Plasma concentration of docetaxel (free and total)(After completion of infusion administration on Day 1 of Cycle 1)
研究者
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