NCT06273800招募中不适用
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- pCR rate
研究概览
简要总结
This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment.
- •Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. ,
- •Aged < 60 years
- •Women having a (regular) physiological menstrual cycle
- •Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy
- •Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy)
- •Signed written informed consent
排除标准
- •current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as:
- •Oral contraception (OAC)
- •Hormonal intra-uterine device (IUD, Mirena)
- •No ovarian function suppression to preserve fertility
- •Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil
- •Currently pregnant and / or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.
- •- active other malignancy
- •IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment
结局指标
主要结局
pCR rate
时间窗: At 6 months
Number of patients achieving a pathological complete response
次要结局
- Radiological reduction on tumor size(At 6 months)
- Residual cancer burden (RCB)(At 6 months)
- Recurrence-free interval (RFI)(Up to 120 months)
- Pathological reduction on tumor size(At 6 months)
- Distant recurrence free interval (DRFI)(Up to 120 months)
- Overall survival (OS)(Up to 120 months)
研究者
研究点 (2)
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