|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
18 January 2021 |
|
Main ID: |
NCT02236806 |
|
Date of registration:
|
09/09/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab
SAFE |
|
Scientific title:
|
Role of ACE Inhibitors and Beta Blockers as Cardiotoxicity Prevention in Breast Cancer Patients Treated With (Neo)Adjuvant Anthracyclines and/or Trastuzumab: a Four Arm, Placebo Control, Randomized Trial |
|
Date of first enrolment:
|
July 2015 |
|
Target sample size:
|
262 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02236806 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Care Provider).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Lorenzo Livi, MD,Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Azienda Ospedaliero-Universitaria Careggi |
|
|
Name:
|
Icro Meattini, MD,Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Florence |
| |
|
Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Cardiotoxicity
|
|
Breast Cancer
|
|
Intervention(s)
|
|
Drug: Bisoprolol
|
|
Drug: Ramipril
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Global longitudinal strain (GLS)
[Time Frame: at months 6,9,12,24]
|
|
Left ventricular ejection fraction (LVEF)
[Time Frame: at months 6,9,12,24]
|
|
Secondary Outcome(s)
|
|
Indexed left ventricular end diastolic volume (EDVI)
[Time Frame: at months 6,9,12,24]
|
|
Indexed left ventricular end systolic volume (ESVI)
[Time Frame: at months 6,9,12,24]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|