NCT06243432招募中不适用
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥ 18 yo
- •Histological diagnosis of HR+/HER2- advanced breast cancer
- •Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
- •Immunohistochemical expression levels of estrogen and progesterone receptors
- •First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
- •Signing of informed consent approved by local Ethic Committee
排除标准
- •Absence of clinical and pathological data that would compromise the definition of the study endpoints
- •HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
- •Previous chemotherapy for treatment of metastatic disease
结局指标
主要结局
Progression free survival (PFS)
时间窗: Through study completion, an average of 1 year".
PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
次要结局
- Objective response rate (ORR)(Through study completion, an average of 1 year".)
- Incidence of Adverse Events (AEs)(Through study completion, an average of 1 year".)
- Overall survival (OS)(Through study completion, an average of 1 year".)
研究者
研究点 (1)
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