Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)
研究概览
简要总结
Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements.
The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.
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
- •Pathologically confirmed invasive breast carcinoma
- •Candidates for adjuvant chemotherapy for primary breast cancer
- •Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels
排除标准
- •Previous systemic chemotherapy
- •Pregnancy
- •Stage IV breast cancer
研究组 & 干预措施
B
Patient receiving goserelin acetate along with adjuvant chemotherapy
干预措施: Goserelin acetate (Drug)
结局指标
主要结局
The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)
时间窗: Each 3 months
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles
时间窗: Each 3 months
次要结局
- Quality of life (QOL) through-out the study measured by FACT-ES scale.(Each 3 months)