Breast NeoplasmsNCT06958783
Chemotherapy-induced Lipid Profile Changes in Women With Early Breast Cancer
An observational study of Breast Neoplasms and Lipid Profile, run by Cancer center Stefan Kukura Hospital Michalovce at 1 site in Slovakia.
Trial summary
Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, Lipid Profile, Dyslipidemia
- What is being tested?
- Blood lipid monitoring in breast cancer patients during chemotherapy
- How many people
- 56 participants
- Where
- 1 siteSlovakia
- Study dates
- 5 Mar 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Oncology Center, Štefan Kukura Hospital, Penta Hospitals, Michalovce
Michalovce, 07101
About this study
Official title: Detection of Changes in the Lipid Profile in Early-Stage Breast Cancer Patients Undergoing Neoadjuvant or Adjuvant Chemotherapy
Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.
Read the 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.
- Conditions
- Breast Neoplasms, Lipid Profile, Dyslipidemia
- Being tested
- Blood lipid monitoring in breast cancer patients during chemotherapy
- Keywords
- early-stage breast cancer, chemotherapy, cardiovascular risk factor
- Medical subject headings
- Breast Neoplasms, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood lipid monitoring in breast cancer patients during chemotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy. | 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. Receives: Other: Blood lipid monitoring in breast cancer patients during chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Secondary outcomes (1)
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.
Measured: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start5 Mar 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer center Stefan Kukura Hospital Michalovce
- Sponsor type
- University, hospital or other
- Collaborators
- Pavol Jozef Safarik University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958783
- Sponsor's protocol ID
- ONKOMi-Breast cancer study-23
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rusinova 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.
PubMed 41602405
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Changes in the Lipid Profile in Early-Stage Breast Cancer Patients Undergoing Neoadjuvant or Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06958783
- Acronym / sponsor ID
- ONKOMi-Breast cancer study-23
- Conditions
- Breast Neoplasms, Lipid Profile, Dyslipidemia
- Keywords
- early-stage breast cancer, chemotherapy, cardiovascular risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cancer center Stefan Kukura Hospital MichalovceUniversity, hospital or other
- Collaborators
- Pavol Jozef Safarik University
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy. | – | Other: Blood lipid monitoring in breast cancer patients during chemotherapyThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood lipid monitoring in breast cancer patients during chemotherapyThis 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 | Other | Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy. |
Primary outcome
Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy
Time frame: 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.
1 secondary outcome
Correlation of lipid profile changes with menopausal status and body mass index (BMI)
Time frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41602405Rusinova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Lipid Profile, run by Cancer center Stefan Kukura Hospital Michalovce at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy (time frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.