NCT06537752招募中不适用
A Multi-center, Prospective, Observational stuDy to Evaluate EThanOl-induced Symptoms and Safety in Breast Cancer Patients witH Neoadjuvant/Adjuvant Chemotherapy Including Non-ethanol Formulation Docetaxel Before and After Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,052
- 试验地点
- 2
- 主要终点
- Incidence of ethanol-induced symptoms in the initial cycle
研究概览
简要总结
The purpose of this study is to evaluate ethanol-induced symptoms and safety in breast cancer patients with neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Those who voluntarily signed a written personal information collection and usage agreement after receiving an explanation about the objective and method, etc. of this clinical study.
- •Those are confirmed to have primary breast cancers through histological diagnosis and one of the following are applicable.
- •Those who need neoadjuvant chemotherapy as breast cancer patients
- •Those who need adjuvant chemotherapy after breast cancer surgery
- •Those who are scheduled to administer non-ethanol formulation docetaxel according to chemotherapy
- •Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.
排除标准
- •Those are diagnosed with other primary cancer that can influence the treatment or prognosis of primary breast cancers.
- •Those are diagnosed with secondary breast cancers.
- •Those with Stage 0/1 (Tis, N0, M0) or Stage IV (any T, Any N, M1) breast cancers.
结局指标
主要结局
Incidence of ethanol-induced symptoms in the initial cycle
时间窗: From the time of treatment started until the end of follow-up(30 minutes after the treatment)
This outcome's definition is an increase from baseline in the number of ethanol-induced symptoms during or within 30 minutes after the treatment. The initial cycle of non-ethanol formulation docetaxel is collected as 1 cycle.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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