NCT03430479已完成1 期
Phase Ib/II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Phase Ib : dose-limiting toxicity rate
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells) .
- •Patients must satisfy the following criteria for prior therapy:
- •Progressed during treatment or within 12 months of completion of adjuvant hormone therapy.
- •or Progressed while prior hormone therapy for advanced/metastatic breast cancer. Two previous line of hormone therapy for advanced/metastatic disease is allowed.
- •Patients who have hormone therapy that can be expected for advanced /metastatic disease.
- •Patients who have come to be non-responsive more than two line of chemotherapy
- •Prior chemotherapy with anthracycline and taxane agent
- •Cohort A and B
- •Female patients who are histologically or cytologically confirmed to have breast cancer
- •Patients who have distant metastatic lesion as follow
- •More than one bone lesion for radiation therapy
- •Patients with cancer confirmed to be HER2-negative.（
- •Patients with a measurable lesion based on RECIST 1.
- •Patients aged >= 20 years at informed consent
- •Patients with ECOG PS of 0 to
- •Patients without any severe disorder in the major organs.
- •Patients expected to survive for ≥ 90 days.
- •Patients of childbearing potential must be using an acceptable method of contraception to avoid pregnancy and must not be breastfeeding for 18 weeks after the last dose of investigational product
- •Patients who have provided written informed consent themselves.
排除标准
- •Exclusion Criteria:
- •Patients who have neuropathy (more than Grade 2)
- •Patients with any active autoimmune disease or a history of known autoimmune disease.
- •Patients who has a history of pneumonitis or interstitial lung disease.
- •Active, untreated central nervous system metastasis.
- •Patients with pericardial effusion, pleural effusion or ascites requiring treatment
- •Patients with uncontrolled diabetes mellitus
- •Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
- •Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
- •Pregnant or breast-feeding women.
- •Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Patients considered ineligible for participation in this study by their attending physicians
研究组 & 干预措施
Cohort A
Experimental
干预措施: Cohort A (Drug)
Cohort B
Experimental
干预措施: Cohort A (Drug)
结局指标
主要结局
Phase Ib : dose-limiting toxicity rate
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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