PROACT study

A multi-centre, prospective, randomised, open-label, blinded end-point, superiority trial to test the effectiveness of Enalapril (an ACE inhibitor) in preventing cardio-toxicity in patients with breast cancer undergoing anthracycline chemotherapy.

Many patients with breast cancer receive anti-cancer (chemotherapy) drugs following surgery. The most commonly-used chemotherapy drugs are called anthracyclines. Unfortunately, as with all chemotherapy drugs, anthracyclines have side-effects. One of these side-effects is heart damage. Although heart damage is caused at the time of treatment, symptoms may only occur many years later. It is important to know that heart damage only occurs in a small number of patients.  However, when it does occur, it can affect the length and quality of people’s lives. A year after chemotherapy, one in ten patients will have heart damage and be unaware of it; up to one in twenty patients may go on to develop heart failure in the future. This is important because so many patients who receive chemotherapy for breast cancer are cured and go on to live many decades after their diagnosis. Currently, there is no treatment to prevent heart damage caused by chemotherapy.

Drugs called ACE inhibitors are used commonly to treat high blood pressure and other heart conditions. Some early research suggests that these may stop heart damage caused by anthracycline chemotherapy. Patients and doctors now need more information to show whether ACE inhibitors are useful at preventing heart damage.

This study will include one hundred and seventy (170) patients. 85 patients will receive their planned chemotherapy as usual; the other 85 patients will receive their planned chemotherapy and also take an ACE inhibitor called enalapril. Patients taking the enalapril tablets will take these twice per day, beginning before chemotherapy starts, and finishing three weeks after it ends