Skip to main content
OpenTrials
Completed

NCT Number: 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 with doxorubicin, cyclophosphamide, and paclitaxel.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Oncology Center, Štefan Kukura Hospital, Penta Hospitals, Michalovce

Michalovce, 07101, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

Blood lipid monitoring in breast cancer patients during chemotherapy

Other

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

Primary outcomes

  1. Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy

    Time frame: 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.

Secondary outcomes

  1. Correlation of lipid profile changes with menopausal status and body mass index (BMI)

    Time frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.

    Assessment of the association between dynamic changes in fasting lipid parameters (TC, TG, LDL-C, HDL-C) and patients' menopausal status and body mass index (BMI) measured at baseline. The analysis aims to explore potential modifiers of chemotherapy-induced lipid alterations.

Sponsors and collaborators

Lead sponsor

Cancer center Stefan Kukura Hospital Michalovce

Other

Collaborators

  • Pavol Jozef Safarik University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.