Clinical trial NCT06958783: Chemotherapy-induced Lipid Profile Changes in Women With Early Breast Cancer
Official title: Detection of Changes in the Lipid Profile in Early-Stage Breast Cancer Patients Undergoing Neoadjuvant or Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lipid Profile
Dyslipidemia
Keywords: early-stage breast cancer
chemotherapy
cardiovascular risk factor
Lead sponsor: Cancer center Stefan Kukura Hospital Michalovce
Sponsor class: OTHER
Collaborators: name: Pavol Jozef Safarik University
First posted: 2025-05-06
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy
timeFrame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Secondary outcomes:
measure: Correlation of lipid profile changes with menopausal status and body mass index (BMI)
timeFrame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Other outcomes:
Locations:
city: Michalovce
country: Slovakia
facility: Oncology Center, Štefan Kukura Hospital, Penta Hospitals, Michalovce
Study officials:
References: