A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after capecitabine-base chemotherapy.
详细描述
capecitabine-base chemotherapy must be 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •The age is Above 18 years of age, <70 years old
- •HR-positive & HER2-negative
- •Metastatic breast cancer,incurable.
- •No prior chemotherapy for metastatic recurrence, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy as first-line treatment for metastatic lesions
- •Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
- •The basic function of normal bone marrow
- •Functions of liver and kidney is normal
- •Expectation of life is more than 3 months
- •Agreed to take contraceptive measures during treatment
排除标准
- •Previous toxicity was not recovered to 0-1 degrees
- •Central nervous system metastasis
- •Pregnancy or lactation
- •There are uncontrolled infection, myocardial infarction, thrombosis, etc.
- •There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
- •Researchers believe that is not suitable for the study
- •Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
- •Bilateral breast cancer
研究组 & 干预措施
Capecitabine
Capecitabine 1250mg per BSA by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.
干预措施: Capecitabine (Drug)
endocrine therapy
endocrine therapy is be gived as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemotreatment,the medcine will be confirmed by the patient's past-treatment.
干预措施: endocrine therapy (Procedure)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
次要结局
- clinical benefit rate(CBR)(From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years)