Prevention of Cardiac Dysfunction During Breast Cancer Therapy

Summary

Breast cancer is the most common cancer among women. The modern post-surgery treatment with chemotherapy, immunotherapy, radiation and hormone therapy has improved the overall 5-years survival drastically. However, an unwanted effect of the post-surgery treatment is its potentially deleterious effect on the heart resulting in cardiac dysfunction. Angiotensin antagonists are used as part of the heart failure treatment. In smaller studies angiotensin antagonists have shown to have a cardioprotective effect during breast cancer treatment. Sacubitril/valsartan is a potent drug that in addition to an angiotensin antagonist contains a neprilysin inhibitor. Sacubitril/valsartan has proved to be superior to enalapril in chronic heart failure. In this randomized placebo controlled double blind trial we hypothesize that sacubitril/valsartan used concomitantly during anthracycline containing chemotherapy for breast cancer treatment prevents cardiac dysfunction as measured by cardiac magnetic resonance imaging (CMR). PRADA II is a Norwegian multicenter trial intending to recruit 214 patients and follow them for 18 months with CMR, cardiac ultrasound, blood samples, functional capacity tests and health related quality of life questionnaires.

Conditions

• Breast Cancer Female
• Heart Failure

Interventions

DRUG

Sacubitril/valsartan

Target dose 97/103 mg b.i.d .

Sponsors & Collaborators

• University Hospital, Akershus

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Klinbeforsk

  collaborator OTHER

• Norwegian Cancer Society

  collaborator OTHER

• Novartis

  collaborator INDUSTRY

• Torbjorn Omland

  lead OTHER

Principal Investigators

• Torbjørn Omland, MD,PhD,MPH · University Hospital, Akershus

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-31

Primary Completion

2024-09-05

Completion

2024-09-05

Countries

• Norway

Study Locations