This phase 2 trial will investigate the safety of durvalumab (Imfinzi) in combination with standard hormonal treatment for breast cancer (BC). The main outcome will be the response to treatment. The trial is recruiting in Tampa, Florida, US.
Breast cancer (BC) is one of the most common cancers. It affects bothe men and women. Standard care involves surgery to remove the tumor and chemotherapy. New drugs are in development for cancers. Immune-checkpoint inhibitors (ICIs) are a promising type of cancer therapy. Durvalumab is an ICI and blocks a protein called PD-L1. It is licensed to treat advanced lung cancer. It is also under investigation in a number of other cancers including BC.
This trial will investigate the safety of durvalumab in combination with standard hormonal treatment for BC. The main outcome measured will be response to treatment.
Who are they looking for?
This trial will recruit 46 women with BC. Participants must be postmenopausal. The cancer must be categorized as estrogen receptor positive (ER+). It must also be negative for human epidermal growth factor receptor 2 (HER2-). Patients must be willing to undergo a tissue biopsy at the start of the trial and after 1 cycle of treatment. Patients must have adequate organ function, must provide mammogram of both affected and unaffected breast and must have a body mass index higher than 30kg/m2.
Patients cannot take part in the trial if they have inflammatory BC. Patients cannot have received any treatment for BC prior to this study. This includes surgery to remove BC tumors. Previous treatment with PD-L1 (or its receptor, PD-1) inhibitors is excluded. Other exclusion criteria include previous cancers, autoimmune/inflammatory disease, organ transplant, ongoing infection, recent vaccination, uncontrolled seizures.
How will it work
All patients will receive durvalumab in combination with another drug, anastrozole (Arimidex). Anastrozole is an aromatase inhibitor. It is a standard BC drug. Durvalumab will be administered every 4 weeks for 6 cycles. If this is well tolerated, patients will have another 6 cycles of durvalumab treatment.
Patients will be monitored up to 6 months for response to treatment.