ANTI-MULLERIAN HORMONE (AMH) AS A MARKER OF OVARIAN RESERVE IN YOUNG BREAST CANCER PATIENTS RECEIVING CHEMOTHERAPY + GnRH ANALOGUE
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- AMH in response to chemotherapy plus GnRHa
研究概览
简要总结
This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa.
In the present study we propose to determine AMH levels in breast cancer patients, aged <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.
详细描述
Patients will receive 4 to 8 cycles of chemotherapy according to Institutional guidelines. Triptorelin 3.75 will be administered as an intramuscular injection before chemotherapy and every 28 days thereafter for all the duration of chemotherapy in patients with ER negative tumors and for 2 to 5 years in patients with ER positive tumors according to Institutional guidelines. Patients with ER+ve tumour will receive tamoxifen for 5 years at the end of chemotherapy as standard care. A blood sample will be drawn after signed informed consent to determine baseline AMH levels. A blood sample for determination of AMH levels will be collected at the end of chemotherapy and at 12 months after the end of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects, aged <40yr at the time of breast cancer diagnosis
- •Diagnosis of operable breast cancer any T and N, any ER
- •Patients candidate to adjuvant chemotherapy for 4-8 cycles.
- •Patients compliant to adhere to all protocol procedures.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the start of the study treatment.
- •Negative pregnancy test at the study enrolment; fertile women must use effective contraception during chemotherapy
- •Patients must be able to understand and sign written informed consent.
排除标准
- •Presence of distant metastasis
- •Clinically significant cardiovascular disease
- •Psychological or social conditions which might affect study compliance
- •Unstable neurologic function
- •Patients with known allergy to any of the components of the study medication
- •Pregnancy or lactation
- •Any condition that, in the opinion of the physician is likely to affect inclusion of the subject into the study.
研究组 & 干预措施
Triptorelin
Triptorelin 3.75 administered every 28 days, for 4 to 7 injections depending on the number of cycles of chemotherapy
干预措施: Triptorelin (Drug)
结局指标
主要结局
AMH in response to chemotherapy plus GnRHa
时间窗: 18 months
To evaluate AMH levels changes in response to chemotherapy plus GnRHa in order to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa
次要结局
- AMH and menstrual cycle(18 months)
- AMH after chemotherapy(18 months)
- AMH levels >0.2 ng/mL at the 12-month time point(18 months)
研究者
Armando Santoro, MD
Principal Investigator
Istituto Clinico Humanitas