NCT06558084已完成不适用
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse effect
研究概览
简要总结
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients aged 18 years old or more
- •Female patients
- •Histologically proven invasive breast cancer
- •Histologically proven HR-positive and HER2-negative breast cancer
- •Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to
- •Adequate hematological and organs function
- •Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment
排除标准
- •- Male breast cancer patients
- •Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
- •Prior treatment with any CDK 4/6 inhibitor.
- •History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
- •Have active bacterial or fungal infection, or detectable viral infection.
研究组 & 干预措施
Metastatic breast cancer patients
metastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line
干预措施: CDK4/6 Inhibitor (Drug)
结局指标
主要结局
Adverse effect
时间窗: 2 years
assess the toxicity profile
次要结局
- PFS(2 years)
研究者
Asmaa Ali
Assistant lecturer
Ain Shams University
研究点 (1)
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