This phase 2 trial will investigate the effects of tesetaxel combined with targeted therapy drugs in advanced breast cancer (BC).
The main outcomes will be the overall response rate (ORR) and progression-free survival (PFS). This trial is recruiting in Boston, MA and East Setauket, NY.
Some breast cancer (BC) types do not respond to standard treatment. One type of BC is triple-negative breast cancer (TNBC). Another type is HER-2-negative. Chemotherapy (CT) is a standard treatment for BC. CT drugs target cells that grow rapidly. This includes cancer cells. There are several different types of CT drugs. One type is called taxanes. Tesetaxel is a new taxane drug that is currently developed for advanced cancer. In recent years new drugs has been developed to treat advanced cancers. Drugs that block the PD-1/PD-L1 pathway are particularly promising. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors. Atezolizumab (Tecentriq) is a PD-L1 inhibitor. These are targeted therapies.
This trial will investigate the effects of tesetaxel combined with targeted therapy in advanced BC. The main outcomes will be ORR and PFS.
Who are they looking for?
This trial will recruit 130 patients with advanced TNBC. This means the tumor must be negative for HER2 and hormone receptors. Patients with HER-2-negative only tumor will also be included if they are 65 years or older. Patients that will be treated with a PD-1/PD-L1 inhibitor must provide a tumor sample. Participants must have adequate kidney, liver and bone marrow function.
Participants cannot have had prior treatment with pembrolizumab, nivolumab or atezolizumab. Treatment with other PD-1/PD-L1 or CTLA-4 inhibitors is also an exclusion criterion. Other exclusion criteria are a history of autoimmune disease, active infection, recent vaccination or organ transplantation.
How will it work
Patients will be assigned to one of 4 groups. One group (HER-2-negative patients) will receive tesetaxel alone. Each of the other groups (TNBC) will receive tesetaxel and either pembrolizumab, nivolumab, or atezolizumab.Tesetaxel will be administered orally once every 3 weeks. Pembrolizumab, nivolumab or atezolizumab will be administered intravenously once every 3 weeks. The study will last up to 3.5 years.