NCT05430399招募中3 期
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial
Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2022年6月21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
- 招募中
- 发起方
- 入组人数
- 349
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent form;
- •Women aged ≥ 18 years;
- •Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;
- •The primary tumor and metastases (if re-biopsy was performed) were both HER2-negative;
- •Eastern Cooperative Oncology Group (ECOG) score [0-1] points;
- •Patients must have metastatic disease that is evaluable on imaging: including at least one measurable lesion (assessed according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)); or only non-measurable disease as defined by RECIST 1.1 , especially in patients with bone metastases only, while the disease could be documented/assessed by bone scan, PET or MRI;
- •Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomization;
- •No previous chemotherapy for advanced breast cancer ;
- •For HR+ breast cancer patients shall meet one of the two criteria below: a) radiographically confirmed recurrence or progression within 2 years of adjuvant endocrine therapy; b) received at least one line of endocrine therapy in the recurrence or metastasis stage;
- •Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior antineoplastic therapy. However, patients with any grade of alopecia were allowed ;
- •Patients with asymptomatic CNS metastases may be enrolled, if:
- •Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or
- •Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;
- •Adequate hematological, hepatic and renal function;
- •Women of childbearing potential must agree to use a contraceptive method during the treatment period and for at least 90 days after the last dose of experiment treatment;
- •Life expectancy of at least 12 weeks;
- •Patients must be able to participate and comply with treatment and follow up.
排除标准
- •HER-2 positive (IHC 3+, or FISH positive);
- •Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
- •Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;
- •Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;
- •Experienced grade ≥ 3 nervous system-related adverse events after treatment with anti-microtubule drugs;
- •Symptomatic central nervous system metastases;
- •Pregnant or lactating women;
- •Known or suspected hypersensitivity to any of the study drugs or excipients;
- •Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that precludes study treatment implementation or follow-up ;
- •Any other condition that the investigator considers inappropriate to participate in this trial .
- •Use of corticosteroids is prohibited.
研究组 & 干预措施
Arm A
Experimental
utidelone
干预措施: utidelone (Drug)
Arm B
Active Comparator
docetaxel
干预措施: docetaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to 60 months
Time from randomization to progression or death (whichever occurred first)
次要结局
- Patient-reported health-related quality of life (QoL): FACT-B total score(up to 60 months)
- Objective response rate (ORR)(up to 60 months)
- Time to response (TTR)(up to 60 months)
- Overall survival (OS)(up to 60 months)
- Duration of response (DOR)(up to 60 months)
研究者
wang shusen
Chief Physician
Sun Yat-sen University
研究点 (2)
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