A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- University of Alberta
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- The primary objective is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular (LV) remodeling among women with HER2+ early breast cancer.
Study Overview
Brief Summary
While trastuzumab has been shown to prevent recurrences of breast cancer, some women may also experience damage to their heart muscle (including heart failure) as a result of their treatment. The investigators hope to learn if standard medications used in heart failure can prevent heart damage caused by trastuzumab in women with breast cancer. The investigators would also like to know if there are any ways to detect this damage earlier using magnetic resonance imaging (MRI) and blood tests.
Detailed Description
We propose a randomized, placebo-controlled, double-blind study evaluating the efficacy of an ACE-inhibitor (perindopril) or a beta blocker (bisoprolol) for the prevention of LV remodeling among women with early breast cancer scheduled for chemotherapy and one year of trastuzumab. Participants will undergo cardiac MRI at baseline and 3 and 12 months, replacing the usual MUGA, as well as a post-treatment cardiac MRI at 24 months to evaluate long-term effect.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologic diagnosis of HER2 positive breast carcinoma
- •Eligible to receive trastuzumab
- •Age > 18 years
- •Able to give informed consent
- •No contraindications to MRI
Exclusion Criteria
- •Known contraindication to beta-blocker therapy
- •Known contraindication to ACEI therapy
- •Current treatment with ACEI or beta blocker for other indication
- •History of heart failure, cardiomyopathy or baseline LVEF < 50%
Arms & Interventions
1
Intervention: perindopril OR bisoprolol OR placebo (Drug)
Outcomes
Primary Outcomes
The primary objective is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular (LV) remodeling among women with HER2+ early breast cancer.
Time Frame: 3.5 years
Secondary Outcomes
No secondary outcomes reported