Clinical trial · Observational
Diagnosis and Prediction of Taxanes Induced Cardiac Dysfunction
Diagnosis and Prediction of Subclinical Cardiac Dysfunction Induced by Therapy With Taxanes in Patients With Breast Cancer
- 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)
Breast cancer represents the most frequent form of neoplasia in women worldwide, being responsible of 1.6% of annual deaths. Therefore, it is a major public health issue and research in this field should be a priority. Taxanes, such as paclitaxel and docetaxel, are extremely powerful antineoplastic drugs, which alone or in association to anthracyclines, increase survival and lower the recurrence rate of cancer, but their use is limited by cardiotoxicity. Cardiotoxicity can appear early or late after therapy, and may vary from subclinical myocardial dysfunction to irreversible heart failure. Currently, cardiac dysfunction induced by taxanes is diagnosed through classical echocardiographic parameters. However, these cannot detect subtle, early changes of cardiac structure and function. Consequently, description of new parameters, which could detect cardiac dysfunction in an early stage, becomes essential for detecting the group of patients at risk for irreversible heart failure. The objectives of the investigators project, in patients with breast cancer treated with taxanes, are to investigate their mechanisms which lead to cardiac dysfunction, to describe new parameters for the early diagnosis of cardiotoxicity, and to define predictive models for cardiotoxicity. Meanwhile, project will publish the results in prestigious journals, leading to an increase of the visibility of Romanian research internationally.
Conditions
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- TAXANES
- description
- patients with early breast cancer, scheduled to receive taxanes, with doses according to the stage of the disease
Primary outcomes (1)
- measure
- CARDIOTOXICITY PREDICTION SCORE
- timeFrame
- 6 MONTHS, 1 YEAR, 2 YEARS
- description
- To determine the change in left ventricular ejection fraction (LVEF) after 6 months, 1 or 2 years after treatment with taxanes for defining cardiotoxicity (LVEF less than 55% or reduction with more than 10% from baseline).
Secondary outcomes (3)
- measure
- GENETIC DISORDERS AND CARDIOTOXICITY
- timeFrame
- BASELINE
- description
- To test implication of some genetic disorders in predicting cardiotoxicity, mainly through decrease of antioxidant capacity;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 18 years 2. Informed consent signed 3. Patients with early breast cancer, scheduled to receive chemotherapy 4. LVEF \> 50% and LVSF \> 20%. Exclusion Criteria: 1. Any history of cardiovascular disease and/or active cardiovascular treatment 2. Diabetes mellitus 3. Mediastinal irradiation.
References
Publications (0)
Data not yet available