NCT02518191已完成3 期
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China
Xiangyun Zong2 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 2
- 主要终点
- Number of Participants With Premature Ovarian Insufficiency
研究概览
简要总结
This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women 18 to 49 years of age are eligible for enrollment
- •Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
- •Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
- •Human chorionic gonadotropin negative by urine test before entering the group.
- •Informed consent, understanding and compliance with the requirements of the study.
- •No significant chronic disease and any organ dysfunction.
排除标准
- •Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
- •Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
- •Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
- •Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
- •Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
- •Allergic to active or inactive excipients of GnRHa is an exclusion criterion.
研究组 & 干预措施
GnRHa group
Experimental
Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.
干预措施: GnRHa (Drug)
结局指标
主要结局
Number of Participants With Premature Ovarian Insufficiency
时间窗: 1 years
The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH\<0.5ng/mL in this study.
次要结局
- Survival Rate(5 years)
研究者
Xiangyun Zong
Chief
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
研究点 (2)
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