Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Mature Oocyte Yield
研究概览
简要总结
Latrogenic infertility as a result of cancer treatment has a profound effect on long-term quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to cancer treatment has been associated with improved quality of life, with a potential ability to reduce long-term decision-related regret in cancer survivors. Though letrozole plus gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in ovarian stimulation cycles for fertility preservation in patients with estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to improved oocyte yield. Improved knowledge about the efficacy of these medications, with regard to oocyte yield, has the potential to significantly improve quality of life in reproductive-age breast cancer survivors.
详细描述
Purpose:
Our primary objective is to determine whether concomitant administration of tamoxifen 20 mg oral with gonadotropins (tamoxifen-gonadotropin) versus a starting dose of letrozole 5 mg oral with gonadotropins (letrozole-gonadotropin) will result in a difference in mature oocyte yield during our routine ovarian stimulation protocol for fertility preservation for Estrogen-Receptor-Positive (ER+) breast cancer.
Specific Aims: Each of the following aims will include a primary comparison and secondary comparisons.
Primary aim: The primary aim will be to compare patients with ER+ breast cancer who are treated with letrozole-gonadotropin versus patients with ER+ breast cancer who are treated tamoxifen-gonadotropin with regard to ovarian stimulation outcomes.
- Primary comparison:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •New breast cancer diagnosis
- •Has not yet begun chemotherapy
- •Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
- •Age 18 years old or greater
排除标准
- •Chemotherapy has already commenced or been completed
- •History of recurrent breast cancer (with a prior history of chemotherapy)
- •Stage IV breast cancer diagnosis (metastases remote from the breast)
- •Patient's oncologist advises against the trial - in which case they can choose to receive stimulation with letrozole+gonadotropin
- •Does not plan to undergo ovarian stimulation and oocyte retrieval prior to diagnosis
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
- •Age less than 18 years old
研究组 & 干预措施
Randomized ER Positive Participants (Letrozole)
Participants will receive 5 mg of letrozole with the first day of non-investigational gonadotropin (letrozole-gonadotropin) and stopped on the day of oocyte retrieval.
干预措施: Letrozole (Drug)
Randomized ER Positive Participants (Tamoxifen)
Participants will receive 20 mg of tamoxifen with the first day of non-investigational gonadotropin (tamoxifen-gonadotropin) and stopped on the day of oocyte retrieval
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Mature Oocyte Yield
时间窗: Up to 2 weeks
To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation. An Effect Size of 3 mature oocytes, based on clinically significant difference of 2 embryos to transfer. An average of 2 embryos are transferred per freeze-thaw cycle. If \~75% of mature oocytes will become embryos that can be frozen, then 3 mature oocytes should yield \~2 embryos for transfer. This effect size would effectively mean an additional event of embryos transferred.
次要结局
- Compare change in estrogen levels during the ovarian stimulation cycle(Up to 2 weeks)
- Compare change in progesterone levels during the ovarian stimulation cycle(Up to 2 weeks)
- Compare change in androgen levels during the ovarian stimulation cycle(Up to 2 weeks)
- Compare change in estrogen in follicular fluid(Up to 2 weeks)
- Compare change in letrozole in follicular fluid(Up to 2 weeks)
- Compare change in tamoxifen in follicular fluid(Up to 2 weeks)
- Compare duration of stimulation (days) and total gonadotropin dose(Up to 2 weeks)
- Number if competent oocytes on day 3 of embryo culture(Up to 2 weeks)
- Number if competent oocytes on day 5 of embryo culture(Up to 2 weeks)