Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients Undergoing Embryo or Oocyte Cryopreservation: A Prospective Controlled Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Breast cancer relapse free survival after ovarian stimulation
研究概览
简要总结
Breast cancer patients are commonly treated with drugs that eggs present in the ovary and may reduce their chance for getting pregnant. Their fertility can be preserved by stimulating their ovaries, collecting multiple eggs, fertilize them in the lab and freeze them. Ovarian stimulation increase their estrogen levels in blood.this may stimulate their cancer and increase chance for recurrence. If a medicine that prevent estrogen rise is used (letrozole), this may increase the safety of stimulation. In this study we compared ovarian stimulation in breast cancer patients using letrozole with those who did not undergo stimulation and showed that there is no increase risk for recurrence after a median follow up of 2 years
详细描述
215 women with breast cancer were evaluated for fertility preservation before chemotherapy. Of those, 79 elected to undergo controlled ovarian stimulation (COH) with letrozole and gonadotropins for embryo or oocyte cryopreservation. The 136 patients who declined served as controls.There were no significant differences between the study and control groups regarding age at diagnosis, breast cancer prognostic parameters (tumor size, grade, number of positive lymph nodes, estrogen receptor status, her2-neu overexpression and vascular space invasion), and chemotherapy regimens. There was no difference between the two groups in the projected 10 year relapse, breast cancer specific mortality or overall mortality. There were 3 recurrences or contralateral breast cancers (2 distant, 1 locoregional) in the letrozole group, and 11 in the control group (9 distant, 1 locoregional, 1 contralateral breast).
Comparison; breast cancer patients that underwent ovarian stimulation with letrozole+gonadotropins and those who declined ovarian stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age 18-45 years
- •Biopsy proven breast cancer
- •No prior chemotherapy or oophorectomy
- •Regular menstrual cycles
- •Normal basal FSH and estradiol
排除标准
- •Stage 4 breast cancer
研究组 & 干预措施
letrozole
ovarian stimulation after breast cancer diagnosis and before breast cancer treatment
干预措施: Ovarian stimulation in vitro fertilization cryopreservation (Procedure)
control
No ovarian stimulation before breast cancer treatment
结局指标
主要结局
Breast cancer relapse free survival after ovarian stimulation
时间窗: after chemotherapy to end of follow up
次要结局
- Estradiol level, number of embryos cryopreserved, clinical pregnancy rate, ovarian reserve after chemotherapy(during stimulation, after stimulation and 1-2 years after chemotherapy)
研究者
kutluk oktay
PI
New York Medical College