NCT03071926Unknown2 期
Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients With Primary Endocrine Resistant Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Metronomic PLD in Patients with Primary Endocrine Resistant ABC
详细描述
Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients with Primary Endocrine Resistant Advanced Breast Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with age between 18 and 75 years old
- •Life expectancy longer than 3 months
- •Histological proven unresectable recurrent or metastatic HR positive/HER2 negative breast cancer
- •Primary endocrine resistance is defined as: a relapse while on the first 2 years of adjuvant ET, or PD within first 6 months of first-line ET for MBC, while on ET
- •At least one measurable disease according to RECIST 1.1(except for bone metastasis only)
- •No radiation therapy within 4 weeks prior to enrollment
- •Normal function of major organs: Hb ≥ 90 g/L (no blood transfusion within 14 days) ;ANC ≥1.5×109 /L；PLT ≥75×109 /L；TBIL≤
- •5×ULN; ALT、 AST≤ 3×ULN（ALT、 AST≤ 5×ULN with hepatic metastases）; serum Cr ≤ 1×ULN
- •Be willing to participate in the study, sign informed consent and cooperate with the follow-up
排除标准
- •Previous accumulated or equivalent dose of doxorubicin ≥300mg/m2
- •Intervals of anthracycline-based adjuvant chemotherapy ≤1 year (time between anthracycline-based adjuvant or neoadjuvant chemotherapy and disease relapse)
- •Patients with symptomatic central nervous system metastases. Except for patients with stable and asymptomatic brain metastases for at least 8 weeks and no need for glucocorticoids or mannitol treatment before the trial and at least one measurable lesion outside the brain. Radiotherapy for brain metastases should be completed at least 4 weeks before the registration
- •Pregnant or lactating women and gestational age women who are unable to use effective contraception
- •Treatment with investigational products within 4 weeks before the study
- •Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
- •Severe or uncontrolled infection
- •Psychiatric drugs abuse and unable to withdrawal or mental disorders
- •Other malignancies, except for cured skin basal cell carcinoma and cervical intraepithelial neoplasia.
研究组 & 干预措施
Pegylated Liposomal Doxorubicin
Experimental
Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks
干预措施: Pegylated Liposomal Doxorubicin (Drug)
结局指标
主要结局
PFS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression Free Survival
次要结局
- Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- OS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- CBR(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Xichun Hu
Vice Director of department of medical oncology
Fudan University
研究点 (1)
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