An observational study in Breast Neoplasms, Lipid Profile and Dyslipidemia, sponsored by Cancer center Stefan Kukura Hospital Michalovce. Completed at 1 site in Slovakia. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Cancer center Stefan Kukura Hospital Michalovce · Observational
Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 56 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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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.
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.
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
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
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.
Time frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Correlation of lipid profile changes with menopausal status and body mass index (BMI)
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.
Time frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Plan to share: No
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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