Clinical trial · Observational
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
NCT06958783CI-TRIAL-00090371completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Dyslipidemia | — | UNRESOLVED | — |
| Lipid Profile | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood lipid monitoring in breast cancer patients during chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy.
- description
- 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.
- interventionNames
- Other: Blood lipid monitoring in breast cancer patients during chemotherapy
Primary outcomes (1)
- 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.
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRusinova 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