NCT03430466终止2 期
Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Response rate based on RECIST1.1
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged >= 20 years at informed consent.
- •Patients who have provided written informed consent themselves.
- •Patients who have metastatic and/or advanced lesion
- •Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
- •Patients with cancer confirmed to be HER2-negative.
- •Patients with confirmed menopause
- •Patients who have plans of 2nd hormone therapy.
- •Patients with a measurable lesion based on RECIST 1.1
- •Patients with ECOG PS of 0 to
- •Patients without any severe disorder in the major organs.
排除标准
- •Exclusion Criteria:
- •Active or prior documented autoimmune disease within the past 2 years.
- •Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
- •Patients with central nervous system metastasis
- •Patients with life-threatening disease.
- •Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
- •Patients who have received live vaccination within 30 days before start of the investigational products.
- •Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
- •Patients considered ineligible for participation in this study by their attending physicians.
研究组 & 干预措施
Durvalmab&Tremelimumab&Fulvestrant
Experimental
Durvalmab&Tremelimumab&Fulvestrant
干预措施: Durvalmab&Tremelimumab&Fulvestrant (Drug)
结局指标
主要结局
Response rate based on RECIST1.1
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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