Capecitabine Metronomic Chemotherapy Combined With Aromatase Inhibitors in Postmenopausal Hormone-receptor-positive Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
The present study is to determine the adverse effects and clinical efficacy of AI combined with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with Estrogen receptor and/or Progestrogen receptor positive.
详细描述
Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used as first-line and second-line rescue therapy for advanced breast cancer ,third-generation aromatase inhibitors (AI) is the preferred adjuvant endocrine therapy for Postmenopausal hormone-sensitive breast cancer. Study showed that AI combined with metronomic chemotherapy could improve the objective response and clinical benefit in neoadjuvant therapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hormone receptor positive;
- •previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure;
- •patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery.
- •patients with metastatic breast cancer must have evaluable lesions
- •normal laboratory values:
- •informed consent (ethical approval document No. :1112105-1);
- •life expectancy of at least 3 months;
- •Postmenopausal or premenopausal with bilateral oophorectomy.
排除标准
- •have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months
- •organ transplant (except for autologous or allogeneic bone marrow transplantation);
- •have evidences of central nerve system metastases or have a history of mental illness that uncontrol;
- •unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity;
- •unwilling or unable to comply with study protocol or unable to meet the follow up;
- •patients who researchers considered were not suitable to participate.
研究组 & 干预措施
Metronomic Capecitabine and AI
Postmenopausal Hormone receptor positive breast cancer patients who wanted to conserve breast were enrolled to receive capecitabine 500mg/tid p.o plus one of the aromatase inhibitors (AIs):Anastrozole 1mg/day p.o, and who had first line or second line Letrozole therapy failure were switched to capecitabine 500mg/tid p.o plus Exemestane 25mg/day p.o；or Exemestane therapy failure were switched to capecitabine 500mg/tid p.o plus Letrozole 2.5mg/day p.o.
干预措施: Capecitabine (Drug)
Metronomic Capecitabine and AI
Postmenopausal Hormone receptor positive breast cancer patients who wanted to conserve breast were enrolled to receive capecitabine 500mg/tid p.o plus one of the aromatase inhibitors (AIs):Anastrozole 1mg/day p.o, and who had first line or second line Letrozole therapy failure were switched to capecitabine 500mg/tid p.o plus Exemestane 25mg/day p.o；or Exemestane therapy failure were switched to capecitabine 500mg/tid p.o plus Letrozole 2.5mg/day p.o.
干预措施: aromatase Inhibitors (AIs) (Drug)
结局指标
主要结局
adverse events
时间窗: average 10 months
adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)
次要结局
- TTF(average 10 months)
- PFS(average 10 months)
研究者
Guangyu Liu
Vice Director of Department of Surgical Oncology,Cancer Hospital & Institute
Fudan University