This phase 2 study will investigate the safety and effectiveness of olaparib (Lynparza) alone or in combination with durvalumab (Infinzi) in advanced triple negative breast cancer (TNBC).
The main outcome will be progression-free survival (PFS). This study is recruiting in Durham, North Carolina, US.
Breast cancer (BC) is one of the most common cancer types. There are many subtypes of BC. BC subtypes are based on a number of factors. Some BC tumors express specific receptors. Other BC tumors may have specific gene mutations. Triple negative BC (TNBC) is an aggressive form of BC. TNBC cells do not express the three most common factors linked to BC. These are estrogen and progesterone receptors, and the HER-2 gene. There are fewer treatment options for TNBC. New cancer drugs have been developed recently. Olaparib (OPB) is a drug that blocks an enzyme called PARP. Some types of BC use PARP to continue growing rapidly. OPB slows BC tumor growth. Combining OPB with other drugs may further improve survival. Durvalumab (DVB) is an immune-checkpoint inhibitor (ICI) drug. It prevents a protein (PD-1) from interacting with another protein (PD-L1). This helps the immune system to recognize and kill cancer cells.
This study will investigate the safety and effectiveness of OPB alone or in combination with DVB in TNBC. The main outcome will be PFS.
Who are they looking for?
This trial will recruit 60 patients with metastatic TNBC. Patients must have had effective platinum-based chemotherapy. Participants must have a tumor sample for biomarker analysis. Participants must use a reliable method of contraception to prevent pregnancy. Patients should have adequate bone marrow, kidney, and liver function.
Patients cannot take part if they are enrolled in another trial. Patients with autoimmune disease, active infections or taking medication to suppress the immune system cannot take part. Previous treatment with PARP or PD-1/PD-L1 inhibitors is also excluded. Other exclusion criteria include bowel, liver disease, brain metastasis, and any uncontrolled conditions (e.g. hypertension). Patients who had major surgery in the previous 2 weeks or radiation therapy in the previous 4 weeks, a live vaccine in the previous 30 days cannot participate.
How will it work
Patients will be randomly assigned to OPB alone or OPB + DVB. OPM will be taken orally twice a day (300 mg x2). DVB will be administered via an intravenous infusion once every 28 days. Treatment will continue until the disease progresses or side effects develop.
The main outcome will be PFS up to 1 year after treatment.