Observational study on heart risks in elderly women with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.