Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After 2nd-line or Over 2nd-line Therapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 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 single-site 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 ≥Second-line Therapy
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.
- •For recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions
- •No prior use of capecitabine therapy or the use of capecitabine treatment was effective, and the efficacy evaluation was CR/PR/SD more than 6 months.
- •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
- •Capecitabine was ineffective in past treatment
研究组 & 干预措施
Capecitabine
Capecitabine by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.Capecitabine starting dose was the dose used at the end of the combined chemotherapy regimen,eg:1000mg per BSA.
干预措施: Capecitabine (Drug)
endocrine therapy
endocrine therapy will been given as a sequential treatment in Metastatic breast cancer patients who are got benefit in capecitabine-base chemotherapy.The medicine will be confirmed by the patient's past-treatment.
干预措施: endocrine therapy (Drug)
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)
- overall survival(From date of enrolling until the date of death from any cause, assessed up to 3 years)
- Number of participants with Grade 3/4 adverse events(From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years)
- Quality of life(QOL)（1）(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)
- Quality of life(QOL)（2）(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)
研究者
Zhengyabing
Chief Physician
Zhejiang Cancer Hospital