Clinical trial · Observational
Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines
Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment
- 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)
This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium. Principal objectives: 1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged \> or = 65 years 2. To observe the management of cardiovascular risk during and after anthracycline treatment 3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30) Secondary objectives: 1. To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams) 2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment. 3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups 4. To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline 5. To calculate the cardiovascular risk according to SCORE
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- cardiovascular risk factors
- timeFrame
- 15 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * women aged 65 years old or more * with confirmed metastatic breast cancer (MBC) * who will be treated with anthracyclines in first or second line * who have a Karnofsky score at baseline of 50 * who agree and are able to fill in the EORTC QLQ-C30 questionnaire * who gave their informed consent Exclusion Criteria: * women having contra-Indications for anthracyclines * women aged \< 65 years old * with no metastatic breast cancer * who will not be eligible for an anthracycline treatment in first or second line MBC * who have a Karnofsky less than 50 * who disagree or are unable to fill in the EORTC QLQ-C30 questionnaire * women refusing or not having signed their informed consent
References
Publications (0)
Data not yet available