Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months
研究概览
简要总结
Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate.
On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility.
Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports.
Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 ≤ age < 38
- •breast cancer histologically proved
- •under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy
- •verbal agreement given
排除标准
- •metastatic breast cancer
- •non able to follow the design of the study (geographic, social or psychological reasons)
研究组 & 干预措施
Adjuvant treatment
Patients in this group will be offered the option of ovarien cryopreservation as well as the follow up of the follicule stock during chemotherapy.
Neo adjuvant treatment
patients in this group will only have the follow up of the follicule stock.
结局指标
主要结局
change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months
时间窗: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months
variation of percentages of AMH rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content
change from baseline of account of antral follicles (CFA) rate to different time points until 24 months
时间窗: baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months
variation of percentages of CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content
次要结局
- correlation between amenorrhea duration and oncologic outcome (overall and free disease survival)(4 years)
- amenorrhea chemotherapeutically induced (weeks)(4 years)
- correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival)(4 years)