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

NCT06958783 | Completed

• 1 other identifier: ONKOMi-Breast cancer study-23
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms; Lipid Profile; Dyslipidemia

Keywords

early-stage breast cancer; chemotherapy; cardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

• 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.

Study Arms (1)

Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy.

The cohort consists of adult female patients with newly diagnosed early-stage invasive breast cancer (stage IB-IIIB) scheduled to receive standardized neoadjuvant or adjuvant chemotherapy.

Other: Blood lipid monitoring in breast cancer patients during chemotherapy

Interventions

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

Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with newly diagnosed, histologically confirmed early-stage invasive breast cancer (stages IB-IVA) assigned to receive standardized neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel, treated at a single center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer center Stefan Kukura Hospital Michalovce: lead
• Pavol Jozef Safarik University: collaborator

Study Sites (1)

Oncology Center, Štefan Kukura Hospital, Penta Hospitals, Michalovce

Michalovce, 07101, Slovakia

Location

Related Publications (1)

• Rusinova L, Medvedieva J, Santova Z, Kozarova M. Prospective evaluation of chemotherapy-induced dyslipidemia in early breast cancer: implications for cardiovascular risk. Front Oncol. 2026 Jan 12;15:1677835. doi: 10.3389/fonc.2025.1677835. eCollection 2025.

  PMID: 41602405 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples collected for the analysis of lipid profiles, including measurements of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)

MeSH Terms

Conditions

Breast Neoplasms; Dyslipidemias

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 6, 2025
• Study Start: March 5, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)