A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 216
- 试验地点
- 10
- 主要终点
- Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
研究概览
简要总结
This is a translational, mutlicentre study. The aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.
详细描述
It is proposed that levels of AMH and inhibin A and B measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition, AMH might give an indication of the possible efficacy of GNRH agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no children and a wish to have some in the future. Older women who have completed their families are less likely to be offered a GNRH agonist.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented histological diagnosis of invasive breast cancer
- •Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)*
- •Female patients aged between 18 and 50 years
- •Premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab
- •OR The patient's last menstrual period had to be within the last 180 days
- •OR An IUD is used for contraception.
- •Ability to provide written informed consent
- •Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible
排除标准
- •Patients with hypothalamic/pituitary disorder
- •History of ovarian tumour
- •Current pregnancy
结局指标
主要结局
Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
时间窗: AMH levels will be taken at specified intervals until 3 years post chemotherapy
To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
次要结局
- Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens(up to 3 years post chemotherapy)
- Correlation between CIA and depletion of ovarian follicular reserve.(up to 3 years post chemotherapy)
- Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients(up to 3 years post chemotherapy)
- Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer(up to 3 years post chemotherapy)