A Phase II Study of the Efficacy and Safety of Adaptive Therapy for Metastatic Refractory Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.
详细描述
This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. The therapy regimen primarily including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study plans to recruit 10 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Understands and voluntarily signs the informed consent form.
- •Minimum life expectancy 16 weeks.
- •Histologically or cytologically confirmed advanced invasive breast cancer.
- •Histological type: human epidermal growth factor receptor 2 (HER2) negative.
- •Prior failure of at least first-line treatment for metastatic disease.
- •At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
- •Premenopausal women must use medically acceptable contraception during the study.
- •Compliance with the study protocol.
排除标准
- •Pregnant or breast feeding.
- •Uncontrolled medical problems.
- •Evidence of active acute or chronic infection.
- •Hepatic, renal, cardiac, or bone marrow dysfunction.
- •Concurrent malignancy or history of other malignancy within the last five years.
- •Patients were unable or unwilling to comply with program requirements.
- •Concurrent use of any other anti-cancer therapy.
研究组 & 干预措施
Treatment arm
Gemcitabine Gemcitabine 1000 mg/m^2 IV on days 1 and 8, cycled every 33 days Vinorelbine 25 mg/m^2 IV on days 1 and 8, cycled every 33 days Eribulin 1.4 mg/m^2 IV on days 1 and 8, cycled every 33 days
干预措施: Gemcitabine, Vinorelbine, or Eribulin (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 12 months
The interval time from the date of initiation treatment after recruit to the date of the first documented disease progression or death due to any cause.
次要结局
- Occurrence and severity of adverse events (AEs)(12 months)
研究者
Zhong-yu Yuan
Clinical Professor
Sun Yat-sen University