Clinical trial · Observational
CARDIOCARE Prospective Clinical Study
CARDIOCARE Prospective Clinical Study An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient With Breast Cancer Therapy Induced Cardiac Toxicity
- 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 a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Behavioral | — | UNRESOLVED |
| Intervention group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group
- description
- Wearables/sensors and ePsycHeart App
- interventionNames
- Behavioral: Control group
- label
- Intervention group
- description
- Wearables/sensors and ePsycHeart App and eHealtHeart
- interventionNames
- Behavioral: Intervention group
Primary outcomes (1)
- measure
- Evaluation of the onset of cardiotoxicity
- timeFrame
- 12 months
- description
- Subclinical cardiotoxicity is defined as preserved Left Ventricular Ejection Fraction (LVEF) with \>15% reduction in Global Longitudinal Strain (GLS) relative to baseline and/or new rise in cardiac Troponin I or Natriuretic peptides levels in plasma. Clinical cardiotoxicity is defined as the reduction of LVEF by ≥ 10% from baseline to a value below 50%, incurred at any timepoint during study Follow Up (FU)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will undergo neoadju-vant and/or adjuvant treatment with regimens including anthracyclines and/or taxanes. 2. Women ≥ 60 years with a diagnosis of HER2-positive locoregional breast cancer who will undergo neoadjuvant and/or adjuvant treatment with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab). 3. Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will undergo neoadju-vant and/or adjuvant treatment with endocrine therapies +/- CDK 4/6 inhibitors. 4. Women ≥ 60 years with HER2-positive metastatic breast cancer who will undergo first-line therapy with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab +/- chemotherapy). 5. Women with age ≥ 60 years before starting the aforementioned treatment for breast cancer. 6. Women eligible ≥ 60 years who will undergo first-line therapy in the metastatic setting with any type of treatment (chemotherapy, immunotherapy, biological agents). 7. Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures 8. Written informed consent. 9. Participant affiliated to a social security system. 10. Life expectancy of at least 12 months. Exclusion Criteria: 1. Age \< 60 years. 2. Diagnosed severe psychiatric or neurological disorders that might impair the ability to give informed consent.
References
Publications (1)
- DERIVEDSacco GGA, Mazzocco K, Constantinidou A, Papakonstantinou A, Mauri D, Kalliatakis G, Tsiknakis M, Ribnikar D, Tsekoura D, Aidarinis V, Keramida K, Oikonomopoulos P, Antoniades A, Brown C, Rizzi F, Bucur A, Pacella E, Karanasiou G, Cardinale D, Cipolla C, Munzone E, Fotiadis D, Curigliano G, Pravettoni G. An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study. JMIR Res Protoc. 2025 Aug 14;14:e63455. doi: 10.2196/63455. PMID 40810441