A Multicentre Prospective Cohort Study: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Proportion of patients who developed LDL-C abnormalities in 3 groups
研究概览
简要总结
Previous studies have shown differences in the effects of different endocrine drugs on blood lipids in breast cancer, and dyslipidaemia is a major risk factor for cardiovascular disease, and it has been previously reported that the leading cause of death in postmenopausal patients with breast cancer is cardiovascular disease, but the effects of endocrine drug therapy on blood lipids in young breast cancer patients (age ≤40) are not clear. Previously, our group conducted a preliminary retrospective analysis of young patients on endocrine therapy and found that dyslipidaemia was also a common adverse effect of treatment in young breast cancer patients; therefore, dyslipidaemia induced by antineoplastic therapy not only occurs in postmenopausal patients, but is also prevalent in premenopausal and even younger patients. Therefore, this study intends to evaluate the effects of different treatment regimens on lipids in early-stage young breast cancer patients and to explore the optimal timing of lipid-lowering drug interventions to provide a basis for clinical practice.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG score 0-1
- •Resectable breast cancer
- •No distant metastases on postoperative imaging assessment
- •Patients proposed for (neo)adjuvant therapy
- •No previous oral lipid-lowering drugs, serum LDL-C level within normal range, i.e. LDL-C value: <3.4 mmol/L
- •No fatty liver by liver ultrasound/CT examination
- •No major organ dysfunction
排除标准
- •Patients with pre-existing hyperlipidaemia, coronary heart disease, fatty liver disease, or who have received or are receiving lipid-lowering medication
- •Enrolled in another study or less than or equal to 4 weeks since discontinuation of other medications
- •Presence of severe dysfunction of vital organs
- •Patients with other malignancies (except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumours that have been cured for at least 5 years)
- •Acute infectious diseases or chronic infectious diseases in active stage
- •History of uncontrolled epilepsy, central nervous system disease or mental disorder
结局指标
主要结局
Proportion of patients who developed LDL-C abnormalities in 3 groups
时间窗: 2 years
Observe and compare differences between groups
次要结局
- Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups(2 years)
- Proportion of patients developing fatty liver in 3 groups(2 years)
研究者
PENG YUAN
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences