RETROSPECTIVE STUDY OF OUTCOME OF CDK4/6 INHIBITORS IN METASTATIC LUMINAL A AND LUMINAL B BREAST CANCER
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
This study is a retrospective review aimed at evaluating the real-world outcomes and clinical efficacy of CDK4/6 inhibitors (such as Palbociclib, Ribociclib, or Abemaciclib) in patients diagnosed with metastatic luminal A and luminal B breast cancer. The study will assess how patients responded to these treatments based on their specific breast cancer subtype (Luminal A vs. Luminal B) by reviewing their medical records.
详细描述
This is a retrospective, observational cohort study conducted at Sohag University Hospital].
The study will include medical records of female patients diagnosed with metastatic Luminal A and Luminal B breast cancer who received CDK4/6 inhibitors as part of their treatment regimen between 2021 and 2026 Data will be collected regarding Patient demographics and baseline clinical characteristics. Pathological features (Hormone receptor status and Ki-67 levels to differentiate Luminal A and B).
Treatment duration and response rates. Outcomes such as Progression-Free Survival (PFS) and Overall Survival (OS), as well as documented adverse effects.
The primary objective is to compare the clinical outcomes and effectiveness of CDK4/6 inhibitors between the Luminal A and Luminal B metastatic breast cancer subgroups in a real-world setting.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are more than 18 years old at time of diagnosis and less than 80 years
- •metastatic breast cancer luminal A and luminal B of either sex
排除标准
- •patients diagnosed with double malignancy
- •patients with incomplete medical records
- •patients with organ failure
结局指标
主要结局
progression free survival
时间窗: Up to 4 years أو From initiation of CDK4/6 inhibitor therapy to disease progression or death, up to 4 years.
Progression-free survival is defined as the time from initiation of CDK4/6 inhibitor therapy until documented disease progression or death from any cause.
Progression-Free Survival (PFS)
时间窗: From the date of therapy initiation up to 4 yrs
PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first.
Progression-Free Survival (PFS)
时间窗: From the date of therapy initiation up to 4 years (the period of retrospective medical records review).
PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first.
次要结局
未报告次要终点
研究者
Abrar Mohamed Ahmed
M.Sc. Candidate, Department of Clinical Oncology, Sohag University
Sohag University