This phase 3 trial will investigate the effectiveness of pembrolizumab (Keytruda) in combination with pre-surgery chemotherapy and after-surgery hormonal therapy in patients with high-risk early-stage breast cancer (BC). The main outcomes to be measured will be the response to treatment and survival.
Breast cancer (BC) is one of the most common cancers worldwide. There are a number of different strategies to treat BC. Some cancers express specific proteins on their surface. These cancers can be treated by targeting these proteins. One type of BC expresses the estrogen receptor (ER+) and does not express human epidermal growth factor receptor (HER-). ER+/HER- BC is usually treated with chemotherapy and endocrine (hormonal) therapy. These are considered standard therapy. Surgery to remove the tumor is also performed. Pembrolizumab is a new cancer drug. It works by enabling immune cells to identify and kill cancer cells.
This trial will investigate the effectiveness of pembrolizumab in combination chemotherapy before surgery and endocrine therapy after surgery for BC. The main outcomes will be the response and survival rates.
Who are they looking for?
This study will include 1140 patients with ER+/HER- BC. Patients can take part in the trial if they have confirmed BC and have a recent tumor biopsy (sample). Patients should have adequate organ function. Highly effective contraception must be used by all participants, up to 1 year after the end of treatment.
Patients cannot take part in the trial if they have BC in both breasts. Patients with autoimmune or immunodeficiency disease, heart disease, active infection, previous BC, allergies to study medication cannot participate. Patients cannot take part in the trial if they are pregnant, breastfeeding or trying to conceive.
How will it work
Patients will be randomly assigned to one of two groups. One group will receive pembrolizumab and chemotherapy. After BC surgery, these patients will have pembrolizumab and endocrine therapy. The second group will receive chemotherapy and a placebo prior to surgery. After surgery, they will receive a placebo and endocrine therapy. Patients will be assessed for disease progression and survival during the study and up to 10 years after the study.