Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Collaborator: University of Florence
• Treatments: Bisoprolol; Ramipril; Trastuzumab

Criteria

Inclusion Criteria:

• Female

• Age >18 years

• Non-metastatic histologically confirmed primary invasive breast cancer

• Scheduled to receive neoadjuvant and/or adjuvant anthracyclines with or without anti-HER2 therapy

• Provided informed consent

• Able to swallow capsules

• LVEF > 50%

Exclusion Criteria:

• Pregnant or lactating women

• Treatment with ACE-inhibitors or beta blockers at diagnosis

• History of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) (version 4.0) Grade >2 symptomatic congestive heart failure (CHF), previous myocardial infarction, significant symptoms (Grade>2) relating to LVEF dysfunction, valvular disease, cardiac arrhythmia (Grade>3)