Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.
详细描述
This is a phase II, single center, prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. This study plans to recruit 30 subjects.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has measurable metastatic triple-negative breast cancer, with at least 1 measurable lesion per RECIST criteria.
- •Fail second-line or above anti-tumor treatment
- •Evaluation is stable disease with a trend of progression.
- •Minimum life expectancy 16 weeks
- •Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
- •ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
- •Normal organ function.
- •Has signed a Patient Informed Consent Form.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) score of ≥ 2
- •Patients with severe liver and kidney insufficiency
- •Deferoxamine Ingredients allergy
- •With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
- •Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
- •Researchers consider it is not suitable for participation.
研究组 & 干预措施
Treatment arm
Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy
干预措施: Deferoxamine Plus Chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 6 months
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
次要结局
- progression-free survival (PFS)(6 months)
- overal survival (OS)(12 months)
- clinical benefit rate (CBR)(6 months)
研究者
Zhong-yu Yuan
Professor
Sun Yat-sen University