Status:
UNKNOWN
Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Collaborating Sponsors:
University of Florence
Conditions:
Breast Cancer
Cardiotoxicity
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 wit...
Detailed Description
Over the years, due to the use of new generation therapeutic regimens, as well as the use of advanced radiation techniques, the curability of breast cancer reached an overall 10-year survival rate of ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT02236806
Start Date
July 1 2015
End Date
June 1 2022
Last Update
February 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliero-Universitaria Careggi, Florence University
Florence, Italy, 50141