Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- ovarian failure
研究概览
简要总结
The study is a prospective randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients are stratified according to age (<35years vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients signed the written informed consent.
- •Histologically proven stage I, II, or III breast cancer
- •Must be candidates for adjuvant or neoadjuvant chemotherapy,
- •Must be premenopausal.
- •Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.
排除标准
- •The patients were previous chemotherapy;
- •Evidence of distant metastases;
- •Other malignancies in the previous 5 years.
- •The patients were using GnRHa, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
- •Pregnancy or lactation.
研究组 & 干预措施
standard chemotherapy with goserelin
standard chemotherapy with the GnRH agonist goserelin
干预措施: goserelin (Drug)
standard chemotherapy with goserelin
standard chemotherapy with the GnRH agonist goserelin
干预措施: standard chemotherapy (Drug)
standard chemotherapy without goserelin
standard chemotherapy without goserelin
干预措施: standard chemotherapy (Drug)
结局指标
主要结局
ovarian failure
时间窗: 2 years
Ovarian failure is defined as amenorrhea for the preceding 6 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 2 year after the end of chemotherapy.
次要结局
- pregnancy(5 year)
- DFS OS(5 year)
- Time to the resumption of menstrual activity(2 year)
- FSH,E2,AMH(2 year)
- Ovarian dysfunction(1 year)