NCT06103032已完成不适用
Long-term Survival of Breast-conserving Surgery Versus Mastectomy in Asymptomatic Screen-detected Unilateral and Bilateral, Unifocal and Multifocal, Young and Elderly Non-palpable Breast Cancer Among Chinese Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- The prognosis was compared between BCS and Mx patients
研究概览
简要总结
We performed this study on a consecutive cohort of women with asymptomatic screen-detected NPBC. The clinicopathological characteristics, 10-year relapse-free survival (RFS) and overall survival (OS) were compared between BCS and Mx patients among different subgroups.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- •Age of at least 18 and at most 90 years. Performance status (Karnofsky-Index) >80%. Chemotherapy is necessary before or after surgery. No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
- •Life expectancy of at least 2 years, disregarding the diagnosis of cancer. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- •Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.
排除标准
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- •Local recurrence and/or metastasis of breast cancer. No need of chemotherapy. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
- •Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- •Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
结局指标
主要结局
The prognosis was compared between BCS and Mx patients
时间窗: 15 years
The clinicopathological characteristics were compared between BCS and Mx patients
时间窗: 15 years
次要结局
未报告次要终点
研究者
研究点 (1)
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