Study of Pembrolizumab and Cyclophosphamide for Patients with Inflammatory Breast Cancer on the Chest Wall
This trial is specifically focused on a rare and aggressive form of breast cancer that has spread to the chest wall. It combines two treatments: pembrolizumab, which helps the immune system fight cancer, and cyclophosphamide, a chemotherapy drug used in low doses over an extended period.
Who can participate: Patients must have breast cancer that has spread to the chest wall and cannot be removed by surgery, confirmed by biopsy showing certain markers like PDL1 or tumor infiltrating lymphocytes. They should have already received treatments such as chemotherapy or radiation therapy. Participants need to be fully active or have some symptoms but still capable of light work. Female patients of childbearing age must use birth control during the study and for 120 days after the last dose, and must have a negative pregnancy test before starting. Male patients must also agree to use birth control. Patients must have normal organ function based on laboratory tests, be expected to live for more than 3 months, be at least 18 years old, and provide tissue samples for testing.
Who cannot participate: Patients who have had a recent heart attack or severe heart problems, active infections requiring antibiotics, are pregnant or breastfeeding, have another uncontrolled type of cancer, have had an organ transplant, have a known allergy to the study drugs, are currently in another clinical trial, have severe liver or kidney disease, have a history of autoimmune diseases where the immune system attacks the body, or have received certain vaccines within a specific timeframe before the study are excluded.
What the trial is testing: The study will assess how effective pembrolizumab and cyclophosphamide are when used together in controlling cancer and improving quality of life. The treatment period lasts up to 24 months. Researchers will examine outcomes such as how long patients live without the cancer getting worse and how long the response to treatment lasts. Regular follow-up visits will monitor treatment response and side effects, with periodic imaging tests to assess the disease's response.
Investigational drugs: Pembrolizumab is an immunotherapy given as an intravenous infusion that blocks a specific protein on cancer cells, allowing the immune system to better recognize and attack them. Metronomic cyclophosphamide is taken orally as a tablet in a low-dose, continuous manner to minimize side effects while targeting cancer cells by interfering with their DNA and preventing them from growing and dividing.