This phase 3 trial aims to evaluate how effective pembrolizumab (Keytruda) is at treating triple negative breast cancer. The main outcome to be investigated is the invasive disease free survival. Other outcomes include the overall survival (time from treatment until death from any cause) and side effects. This trial is taking place in various states across the USA.
Pembrolizumab is a monoclonal antibody that has been used to treat many cancers. It works by stopping the cancer cells growing and spreading. It is thought that pembrolizumab may be effective in treating triple negative breast cancer.
The study will evaluate the effectiveness of pembrolizumab in triple negative cancer by looking at invasive disease free survival (time from treatment until invasive disease).
Who are they looking for?
This study will recruit 1000 patients who have triple negative breast cancer. Patients should have normal blood test results. Patients are eligible if they have had chemotherapy followed by surgery. Patients must be willing to use a method of contraception for the duration of the study.
Patients who have had a prior cancer cannot take part. Patients who have hepatitis C, hepatitis B or any autoimmune disease are excluded from this study. Patients who have metastatic breast cancer are not eligible as well as patients who have been treated with immunotherapy.
How will it work
Patients will be randomly divided into two groups. One group will receive pembrolizumab on days 1 and 22 every 42 days for a period of 52 weeks. The other group will receive no treatment and will be monitored every 12 weeks for one year, every 6 months for 4 years and then every year for 5 years.
The effectiveness will be measured by comparing the rate of invasive disease free survival between the two groups. Invasive disease free survival is found by obtaining biopsy samples from patients. Patients may be followed for a period of up to 10 years.