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SAFE: Cardiotoxicity Prevention in Breast Cancer
NCT02236806Phase 3
Key facts
- Status
- Unknown
- Start
- Jul 2015
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Modality
- Orthosteric Ligands
- Drugs
- bisoprololramipril
- Conditions
- Cardiotoxicity
01
Overview
Phase 3, randomised, double-blind trial of bisoprolol and ramipril in Cardiotoxicity (4 arms), sponsored by Azienda Ospedaliero-Universitaria Careggi. Primary endpoints: Left Ventricular Ejection Fraction at 24 months and Global Longitudinal Strain at 24 months. Status: unknown.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Bisoprolol + Ramipril
Bisoprolol 5mg + Ramipril 5mg daily
Bisoprolol + Placebo
Bisoprolol 5mg + Placebo daily
Ramipril + Placebo
Ramipril 5mg + Placebo daily
Placebo
Placebo daily
03
Who it enrols
Adult females with non-metastatic breast cancer scheduled for anthracycline-based chemotherapy, with LVEF > 50%, excluding those with prior heart failure or significant cardiac history.
04
Endpoints
Primary
Left Ventricular Ejection Fraction
Global Longitudinal Strain
Secondary
Indexed Left Ventricular End Diastolic Volume
Indexed Left Ventricular End Systolic Volume
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