Phase I TNBC Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer
Details
This phase I trial tests the safety, side effects, and best dose of ASTX727 when given together with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ASTX727 with paclitaxel and pembrolizumab may be able to shrink or stabilize triple negative breast cancer for longer than the usual approach alone.
Eligibility
You can join if...
Inclusion Criteria
-Patients at least 18 years of age
-Patients with histologically confirmed triple negative breast cancer
-Patients with the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
-Patients with a known additional malignancy that is progressing or requires active treatment.
-Patients who are receiving any other investigational agents.
-Patients with history of solid organ or bone marrow transplanation.