Detection of Changes in the Lipid Profile in Early-Stage Breast Cancer Patients Undergoing Neoadjuvant or Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy
研究概览
简要总结
Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.
详细描述
Despite the development of highly effective antitumor therapies over the past two decades (e.g., targeted therapy, immunotherapy), chemotherapy regimens including anthracyclines, taxanes, and cyclophosphamide continue to represent a fundamental component of treatment algorithms for early breast cancer, particularly in human epidermal growth factor receptor 2 (HER2)-positive and triple-negative breast cancer (TNBC). While the cardiotoxicity of anthracyclines is well established and routinely monitored by echocardiography, changes in lipid profiles induced by cytotoxic chemotherapy have primarily been reported in retrospective studies with heterogeneous patient populations and measurement protocols.
This prospective, single-center study was designed to evaluate changes in lipid parameters in patients with early-stage breast cancer undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with newly diagnosed breast cancer, stage IB-IIIB, assigned to receive neoadjuvant or adjuvant chemotherapy.
- •Histologically confirmed invasive adenocarcinoma of the breast, including hormone receptor-positive, HER2-positive (human epidermal growth factor receptor 2), or triple-negative breast cancer.
- •Chemotherapy regimen based on doxorubicin, cyclophosphamide, and paclitaxel.
- •Completion of all planned neoadjuvant or adjuvant chemotherapy cycles.
- •Availability of complete lipid profile data at all required timepoints.
- •Exclusion Criteria Prior breast cancer treatment (surgery, chemotherapy, radiotherapy, or systemic therapy).
- •Ongoing or prior treatment with hypolipidemic (lipid-lowering) medications.
- •Incomplete chemotherapy regimen (interrupted or prematurely terminated cycles).
- •Presence of distant metastatic disease at diagnosis.
- •Missing or incomplete lipid profile data.
排除标准
- 未提供
结局指标
主要结局
Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy
时间窗: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Evaluation of dynamic changes in fasting serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) at predefined timepoints during neoadjuvant or adjuvant chemotherapy and at three months after chemotherapy completion.
次要结局
- Correlation of lipid profile changes with menopausal status and body mass index (BMI)(From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.)