Observational study on heart risks in elderly women with breast cancer
CARDIOCARE Prospective Clinical Study An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient With Breast Cancer Therapy Induced Cardiac Toxicity
This study is testing if extra support and monitoring can help older women with breast cancer avoid heart problems while they receive treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 736 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy, immunotherapy, tuzumab |
| Locations | 1 site (Milan) |
| Trial ID | NCT06334445 on ClinicalTrials.gov |
What this trial studies
This prospective observational study focuses on elderly women diagnosed with breast cancer who are undergoing neoadjuvant or adjuvant treatments. It aims to refine risk stratification algorithms to identify patients at higher risk of developing cardiotoxicity from chemotherapy. The study will assess the effectiveness of integrated behavioral and psychological interventions in mitigating or delaying cardiotoxicity. Participants will receive standard care along with supportive care, including wearable devices and mobile evaluations to monitor psychological and cognitive states.
Who should consider this trial
Good fit: Ideal candidates are women aged 60 and older with early or locoregional breast cancer undergoing specific chemotherapy regimens.
Not a fit: Patients who are younger than 60 or those with advanced metastatic breast cancer not receiving the specified treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help prevent or delay heart-related complications in elderly women undergoing breast cancer treatment.
How similar studies have performed: Other studies have shown promise in using psychological interventions to improve outcomes in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriella Pravettoni — European Institute of Oncology
- Study coordinator: Gabriella Pravettoni
- Email: gabriella.pravettoni@ieo.it
- Phone: +39 02 57489.731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.