NCT05402722Unknown2 期
A Phase II Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression Free Survival，PFS
研究概览
简要总结
To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative 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
- •The patients sign the written informed consent.
- •Women aged 18-
- •The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
- •PD-1/PD-L1positive or TMB≥
- •Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •The results of patient's blood tests are as follows:
- •Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL;• Neutrophils≥1.5^9/L; TSH≤ normal upper limit (ULN);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN); • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);• AKP≤ 2.5 ULN; • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.
排除标准
- •The subjects had a central nervous system metastases with clinical symptoms.
- •Subjects with treatment history of PD-1 / PD-L1 inhibitors;
- •Peripheral neuropathy ≥ grade 2; Cardiac dysfunction, hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis and tuberculosis; Autoimmune diseases requiring systemic treatment, and a history of pneumonia (requiring corticosteroid treatment) or interstitial lung disease.
- •Pregnant or lactating women.
- •Other clinical trials of drugs were used in the first four weeks before the first dose.
- •The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
- •Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
- •Congenital or acquired immune deficiency (such as HIV infection);
- •Receive live vaccine within 4 weeks before or during the study period;
- •Patients who are allergic to or contraindicated to the experimental drugs.
- •Other malignant tumors in the past, except cervical cancer and non melanoma skin cancer, which have survived for 5 years without disease.
- •Subjects with any other diseases that are unfit for the treatment.
研究组 & 干预措施
Eribulin in combination with anti-PD-1 antibody
Experimental
Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) .
干预措施: Eribulin (Drug)
Eribulin in combination with anti-PD-1 antibody
Experimental
Participants receive eribulin1.4mg/m2 and anti-PD-1 antibody intravenously (IV) every 3 weeks (Q3W) .
干预措施: anti-PD-1 antibody (Drug)
结局指标
主要结局
Progression Free Survival，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 10 months
The time from the date of randomization to the date of first documented progression or date of death from any cause, whichever came first.
次要结局
- Number of participants with Adverse Events(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months)
- the correlation between the expression of PD-L1 of circulating tumor cells and prognosis(From one week before treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months)
研究者
研究点 (1)
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