A Phase III Randomized Controlled Trial of Prophylactic Cranial Irradiation in Patients With Advanced Triple Negative Breast Cancer Who Had a Response to First Line Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- brain metastasis-free survival
研究概览
简要总结
The purpose of this study is to compare whether prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy could prolong brain-metastasis free survival.
详细描述
This is a phase III, randomized, controlled, open, multicenter clinical trial, designed to assess the efficacy and safety of prophylactic cranial irradiation (PCI) in advanced triple negative breast cancer who response to the first line chemotherapy. Compare the PCI group with the observation group to evaluate brain metastasis-free survival,cumulative risk of brain metastases within 1 year,progression-free survival,overall survival,quality of life measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-cancer 30 (EORTC-QLQ-C30) questionnaire score and function of central nervous measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-brain cancer 20 (EORTC-QLQ-BN20) questionnaire score in women with advanced triple negative breast cancer who response to the first line chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Age of 18 to 65 years;
- •Documented advanced breast cancer, clinical and pathological confirmed;
- •Immunohistochemical examination:ER<1%+, progestin receptor (PR)<1%+, HER-2 -/+ or HER-2(++)with negative result of FISH;
- •A response after four to eight cycles of first line chemotherapy;
- •Life expectancy longer than six months evaluated by investigator;
- •A performance status of 0 to 2, according to the criteria of the World Health Organization (with a higher score indicating a poorer performance status)
- •Less than grade 1( Common Terminology Criteria grade version 4.0) of treatment-related toxicities;
- •Adequate baseline organ function.
排除标准
- •History of another malignancy.
- •Pregnancy or gestation
- •Definite diagnosed of central nervous system (CNS)or leptomeningeal metastases
- •Serious cardiac illness or medical condition
- •Known history of related central nervous system or leptomeningeal disease
- •Cognition impairment or suffering from mental illness
- •Demand a long-term oral administration of psychotropic drugs
- •Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)
结局指标
主要结局
brain metastasis-free survival
时间窗: eight years
time from randomization to brain metastasis
次要结局
- progression-free survival(eight years)
- central nervous function score(eight years)
- life quality score(eight years)
- cumulative risk of brain metastases within 1 year(one year)
- overall survival(eight years)
研究者
wang shusen
Shusen Wang, M.D. Department of Medical Oncology, Sun Yat-sen University Cancer Center
Sun Yat-sen University