This study will investigate the safety and effectiveness of tiragolumab combined with atezolizumab (Tecentriq) and chemotherapy to treat triple-negative breast cancer (TNBC).
The main outcome will be the occurrence of side effects and the objective response rate (ORR).
Breast cancer (BC) is the most common cancer affecting women. BC tumors express protein markers on their surface. The most common markers are estrogen or progesterone receptors. Human epidermal growth factor receptor 2 (HER2) is another marker. Triple-negative breast cancer (TNBC) does not express any of these markers. TNBC can be difficult to treat. Tiragolumab is an experimental drug. It targets a protein called TIGIT. TIGIT is involved in how immune cells respond to cancer cells. Blocking TIGIT may improve the immune systems ability to detect and kill cancer cells.
Some studies suggest combining tiragolumab with atezolizumab may be more effective in treating tumors. Atezolizumab is an approved immunotherapy together with chemotherapy for the treatment of TNBC.
This study will investigate the safety and effectiveness of tiragolumab combined with atezolizumab and chemotherapy to treat TNBC. The main outcome will be side effects and the ORR.
Who are they looking for?
This study will recruit 60 patients with TNBC. Participants must have adequate organ and bone marrow function. The tumors must be positive for the PD-L1 protein in order to be eligible for the trial.
Patients with spinal cord compression or central nervous system disease cannot take part in the trial. Patients with poor heart and lung function cannot participate.
How will it work
All patients will be assigned to treatment with tiragolumab, atezolizumab and chemotherapy. The treatment regimen will depend on the stage of TNBC. Patients that have newly diagnosed or untreated advanced TNBC will be in group A. They will also receive chemotherapy with nab-paclitaxel (Abraxane). They will receive tiragolumab + atezolizumab every 28 days. Patients with early TNBC eligible for surgery will be in group B. They will receive tiragolumab + atezolizumab every 2 weeks. These patients will be separated into 2 groups that will receive different chemotherapy regimens additionally.
The main outcomes will be side effects and the overall response rate at 21 months. Duration of response and survival will also be evaluated.