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临床试验/NCT06299930
NCT06299930已完成不适用

Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy Based on Tumor Subtypes in Patients With Early-stage Breast Cancer: A Multi-institutional Retrospective Cohort Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 10,328 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10,328
试验地点
1
主要终点
Locoregional recurrence-free survival (LRR)

研究概览

简要总结

Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who underwent breast-conserving surgery for invasive breast cancer between 2004 and 2018

排除标准

  • Total mastectomy
  • No pre- or postoperative chemotherapy
  • No radiation therapy
  • Bilateral breast cancer
  • Male breast cancer patients
  • Secondary breast cancer
  • Metachronous or synchronous cancers

结局指标

主要结局

Locoregional recurrence-free survival (LRR)

时间窗: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of LRR, assessed up to 120 months

Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of locoregional recurrence

次要结局

  • Distant metastasis-free survival(Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis, assessed up to 120 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wonshik Han

Clinical Professor

Seoul National University Hospital

研究点 (1)

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