NCT06958783

Chemotherapy-induced Lipid Profile Changes in Women With Early Breast Cancer

Detection of Changes in the Lipid Profile in Early-Stage Breast Cancer Patients Undergoing Neoadjuvant or Adjuvant Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Cancer center Stefan Kukura Hospital Michalovce · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.

Detailed description

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.

Conditions

• Breast Neoplasms
• Lipid Profile
• Dyslipidemia

Interventions

Type	Name	Description
OTHER	Blood lipid monitoring in breast cancer patients during chemotherapy	This intervention is distinguished by its prospective design, enrollment of a clearly defined cohort of adult female patients with newly diagnosed early-stage breast cancer (stage IB-IIIB), administration of a uniform chemotherapy regimen (doxorubicin, cyclophosphamide, paclitaxel), and standardized monitoring of fasting lipid profiles at four precisely scheduled timepoints: pre-chemotherapy, pre-paclitaxel, post-paclitaxel, and three months post-chemotherapy completion

Timeline

• Start date: 2023-03-05
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-05-06
• Last updated: 2025-05-30

Locations

1 site across 1 country: Slovakia