Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, 2x2 Factorial, Double Blind Trial of Candesartan and Metoprolol
Breast cancer is one of the most common malignancies in women. Recent progress in the
detection and treatment of breast cancer has resulted in survival gains, but a consequence
of therapeutic advances is an increasing number of long-term survivors who may be at risk
for development of cardiovascular disease. Several studies suggest that women treated for
breast cancer may be at increased risk for cardiovascular disease, the probable causes being
multi-factorial. Importantly, therapies for breast cancer, including radiotherapy,
anti-HER-2 regimens and certain chemotherapeutic regimens, may increase the risk of
subsequent cardiovascular disease, including atherosclerotic disease, left ventricular
dysfunction, and heart failure.
In the current study we propose to undertake a randomized, placebo-controlled, 2x2
factorial, double-blind trial to assess whether left ventricular dysfunction and/or injury
is preventable, completely or partly, by the concomitant administration of the angiotensin
receptor blocker (ARB), candesartan, and the beta blocker, metoprolol, during postoperative
chemotherapy and radiotherapy.
The proposed study addresses an important clinical problem in a large patient group. Thus,
the possibility of preventing cardiovascular side effects of contemporary therapy for breast
cancer is important both clinically and scientifically.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Change in left ventricular ejection fraction, as assessed by cardiac MRI
Baseline and end of study (up to 72 weeks)
University Hospital, Akershus
Norway: Regional Ethics Commitee