Pooled Analysis of Individual Patient Data of Patients With Early-stage Breast Cancer Treated With Adjuvant Dose-dense Sequential Chemotherapy (Ddsc): a Hellenic Cooperative Oncology Group (HeCOG) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,358
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
The goal of this observational study is to assess survival outcomes and treatment-related toxicity in patients with early-stage breast cancer receiving adjuvant therapies, using high-quality individual patient data pooled from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG), including 3 phase III trials and 4 observational studies. This study aims to assess long-term disease-free survival (DFS) and overall survival (OS), as well as the toxicity patterns associated with dose-dense sequential chemotherapy in intermediate or high-rsk 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with early-stage, surgically resected breast cancer (high or intermediate risk), randomized to receive adjuvant or neoadjuvant dose-dense sequential chemotherapy.
排除标准
- •Patients with metastatic or locally advanced breast cancer at initial diagnosis.
- •Patients who did not receive dose-dense sequential chemotherapy.
研究组 & 干预措施
Early Breast Cancer Cohort
Patients with early-stage breast cancer included in pooled individual patient data from seven clinical studies conducted by the Hellenic Cooperative Oncology Group (HeCOG). Patients received adjuvant treatment.
结局指标
主要结局
Disease-Free Survival
时间窗: From date of diagnosis or surgery to first documented recurrence or death.
Disease-Free survival is defined as the time from diagnosis or surgery to the first documented recurrence of breast cancer (local, regional, or distant) or death from any cause. Patients without an event are censored at the last follow-up.
次要结局
- Overall survival(From date of diagnosis or surgery to death from any cause. Patients alive at last follow-up are censored at that date)
- Treatment-related toxicity(From the first dose of treatment until 5 years after the last dose)
- Overall survival(From the date of diagnosis to the date of death)