Breast Neoplasms, Dyslipidemia, Lipid Profile
Conditions
Keywords
early-stage breast cancer, chemotherapy, cardiovascular risk factor
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.
Interventions
OTHERBlood 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
Sponsors
Pavol Jozef Safarik University
Cancer center Stefan Kukura Hospital Michalovce
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Slovakia
Outcome results
None listed