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临床试验/NCT03983096
NCT03983096已完成不适用

Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer: an Real-world, Multicenter, Case Control Study.

Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 1,213 人开始时间: 2019年7月7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
1,213
试验地点
1
主要终点
Pathological complete remission (pCR)

研究概览

简要总结

Pegylated liposomal doxorubicin or epirubicin in neoadjuvant or adjuvant chemotherapy for breast cancer.

详细描述

This study is an real-world, multicenter, case control study about comparing pegylated liposomal doxorubicin Efficacy and safety of epirubicin in neoadjuvant and adjuvant chemotherapy for breast cancer. As this trial is a retrospective real-world study, investigator have given patients the dose of trial drugs based on real-world principles of diagnosis and treatment and their clinical experience. This trial only collects and analyzes patients' clinical medications, and does not interfere with patients' real-world diagnosis and treatment. A total of 1050 breast cancer patients are collecting from seven centers. 200 cases in neoadjuvant and 850 cases in adjuvant group. The follow-up examinations and assessment of the subjects were followed by real-world medical treatment routines and the visits were completed according to the routine of treatment. Related check and assessments and collect the following data: follow-up 3years or until the disease recurs (whichever occurs first). Adverse events: remission or stability of adverse events caused by follow-up to treatment in the adjuvant treatment group, follow-up for 3 years or until recurrence of the disease in the neoadjuvant treatment group (whichever first occurred).

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with invasive breast cancer diagnosed by menstrual histology in 2014-2018 and receiving neoadjuvant chemotherapy, or patients with invasive breast cancer diagnosed by menstrual histology in 2014-2016 and receiving adjuvant chemotherapy;
  • Chemotherapy regimen recommended by the guidelines for drugs containing anthracycline;
  • Patients whose chemotherapy regimen contains pegylated liposomal doxorubicin or epuroxorubicin;
  • Age :18 -70;
  • Patients with LVEF ≥ 50%.

排除标准

  • Patients with occult breast cancer.
  • Patients receiving two or more anthracyclines during neoadjuvant or adjuvant chemotherapy;
  • Patients who have previously received other chemotherapy regimens;
  • Patients with other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin);
  • Patients complicated with severe infection and in need of treatment;
  • Pregnant or lactating women.

结局指标

主要结局

Pathological complete remission (pCR)

时间窗: one year

pCR was defned as no invasive cancer cells in any slices of the resected breast specimen.

Disease-free survival (DFS)

时间窗: three years.

The length of time after treatment during which no disease in found.

次要结局

  • Breast conserving rate(one year)
  • Adverse event(three years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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