Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS) of the subjects
研究概览
简要总结
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;
- •Elderly women (age ≥ 65years)
- •Failure or relapse from standard chemotherapy or unfit for chemotherapy
- •Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Adequate bone marrow, liver and renal function;
- •Estimated life expectancy of at least 3 months.
排除标准
- •Serious or uncontrolled concurrent medical illness
- •Uncontrolled primary and metastatic brain tumor
- •History of second primary malignancies
- •Having been enrolled in other clinical trials within a month
研究组 & 干预措施
Cyclophosphamide alone
Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in this arm will receive cyclophosphamide 50 mg daily.
干预措施: Cyclophosphamide 50mg (Drug)
Cyclophosphamide plus letrozole for resistant patients
Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
干预措施: Cyclophosphamide 50mg (Drug)
Cyclophosphamide plus letrozole for resistant patients
Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
干预措施: Letrozole 2.5 mg (Drug)
Cyclophosphamide plus letrozole for treat-naive patients
Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
干预措施: Cyclophosphamide 50mg (Drug)
Cyclophosphamide plus letrozole for treat-naive patients
Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily.
干预措施: Letrozole 2.5 mg (Drug)
letrozole alone
Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive letrozole 2.5 mg daily.
干预措施: Letrozole 2.5 mg (Drug)
结局指标
主要结局
Progression free survival(PFS) of the subjects
时间窗: up to approximately 2 years
Time from the randomization date to the start of disease progression or subject death from any cause (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1for elderly metastatic breast cancer subjects).
次要结局
- Evaluate the quality of life for the subjects in the each treatment regimen(up to approximately 2 years)
- Safety of each treatment regimen for the subjects(up to approximately 2 years)
- Compare disease control rate for the subjects(up to approximately 2 years)
研究者
Jun Ren MD, PhD
MD, PhD
Capital Medical University