This phase 3 trial aims to evaluate how well aspirin can work to prevent recurrence of breast cancer. The main outcome to be investigated is invasive disease free survival. Other outcomes include overall survival (time from treatment until death from any cause) and the incidence of heart disease. This trial is taking place in 985 locations across the United States.
The details
Aspirin is a drug used to treat pain, fever and inflammation. It works by stopping the production of prostaglandins that cause pain. Aspirin is being studied in cancer prevention. It is thought that aspirin may reduce the rate of cancer recurrence in breast cancer patients.
The study will evaluate the effectiveness of aspirin to prevent cancer recurrence by looking at invasive disease free survival. Invasive disease free survival is noted as the time frame that a patient has no sign of disease.
Who are they looking for?
This study will recruit 2936 patients who have node positive HER2 negative breast cancer. Patients who have received chemotherapy or radiation in the past can take part. Patients currently undergoing chemotherapy or hormonal therapy can also be included.
Patients who have had a stroke, heart attack, hypertension or gastrointestinal conditions are not eligible for this study. Patients who have had a cancer other than breast cancer in the past 5 years must be excluded. Patients with a known allergy to aspirin cannot be included.
How will it work
Patients will be randomly divided into two groups. One group will receive aspirin orally once a day for five years. The other group will receive a placebo (drug with no active effect) orally once a day for five years.
The effectiveness of aspirin will be measured by invasive disease free survival. This will be done by following patients for a period of up to 5 years.
