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

Cancer center Stefan Kukura Hospital Michalovce

Status: Completed

Conditions: Breast Neoplasms, Neoadjuvant Therapy, Lipid Metabolism, Dyslipidemias, Cardiovascular Diseases

Treatments: Other: Blood lipid monitoring in breast cancer patients during chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06958783

ONKOMi-Breast cancer study-23

Details and patient eligibility

About

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

Full description

Despite the development of highly effective antitumor therapies over the past two decades (targeted therapy, immunotherapy), chemotherapy regimens (anthracyclines, taxanes, cyclophosphamide) still represent a fundamental part of the treatment algorithm for early breast cancer, especially HER 2 (human epidermal growth factor receptor 2) positive and triple negative breast cancer (TNBC). While the cardiotoxicity of anthracyclines is well known and patients undergo regular echocardiographic examination of the heart, the detection of changes in the lipid spectrum due to antitumor chemotherapy is mainly at the level of retrospective analyses with heterogeneous patient populations and measurements. We conducted a monocentric prospective trial to detect changes in the lipid spectrum in early breast cancer patients receiving neoadjuvant or adjuvant chemotherapy based on doxorubicin, cyclophosphamide and paclitaxel.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

56 participants in 1 patient group

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.

Treatment:

Other: Blood lipid monitoring in breast cancer patients during chemotherapy