NCT05731258招募中不适用
Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cardiac safety
研究概览
简要总结
The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-75 years;
- •Primary breast cancer diagnosed histopathologically;
- •Adjuvant chemotherapy regimens include liposomal doxorubicin;
- •ECoG PS score: 0-1 points;
- •Left ventricular ejection fraction (LVEF) ≥ 55%;
- •Estimated survival ≥ 6 months;
- •Major organ function is normal, i.e. meets the following criteria:
- •① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L；② Platelets ≥ 100 × 10 9 /L；③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5
- •× ULN；⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN；⑦ Total bilirubin ≤ 1.5 × ULN；⑧ Serum creatinine ≤ 1.5 × ULN；
- •Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.
排除标准
- •Pregnant, lactating patients;
- •Breast cancer has been found to have distant metastasis;
- •Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
- •Those with severe infection or active peptic ulcer requiring treatment;
- •Allergic to chemotherapy drugs;
- •Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
- •Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
- •Patients who are participating in other clinical trials or within a month.
结局指标
主要结局
Cardiac safety
时间窗: 10 years
Cardiac ejection fraction
次要结局
- Overall survival(10 years)
研究者
研究点 (1)
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