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