This trial is aiming to examine the effectiveness of ipatasertib in combination with atezolizumab (Tecentriq) and paclitaxel (Taxol) for the treatment of advanced triple-negative breast cancer (TNBC) that cannot be surgically removed. The main outcomes to be measured in this trial is survival without progression of the disease and overall survival (OS) of patients.
TNBC is a type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein (a protein found on the surface of some cancer cells). Advanced TNBC is difficult to treat and a combination of targeted therapy and chemotherapy is often an option.
Atezolizumab is an immune therapy used in BC treatment. Paclitaxel is a chemotherapy medication. Ipatasertib is an inhibitor of an important cell signaling process and is related to cancer cell growth. Inhibiting this pathway could prove to be effective in preventing the spread of TNBC cells.
This trial is evaluating the combination of ipatasertib, atezolizumab, and paclitaxel in the treatment of advanced TNBC. The main outcomes will be survival without disease progression and OS.
Who are they looking for?
This trial is looking to recruit 1155 patients with advanced TNBC. Participants must have adequate organ function and measurable disease. Patients must agree to use effective birth control during the trial.
Patients will be excluded from this trial if they have infections requiring anti-microbial treatment, have known HIV infection, known liver disease, current anti-viral treatment, or have had a major surgical treatment within 28 days prior to this trial. Women who are pregnant or actively breastfeeding are also excluded. Participants must not have any serious medical conditions that might interfere with the participation in this trial.
How will it work
There are 5 groups in this trial. Groups 1, 2, and 3 will include patients who test negative for the PD-L1 protein. PD-L1 is a protein present on some cancer cells that keeps the immune system from attacking cancer cells. Group 1 will receive atezolizumab, ipatasertib, and paclitaxel. Group 2 will receive ipatasertib, paclitaxel, and a placebo. Group 3 will receive paclitaxel and 2 placebos in place of atezolizumab and ipatasertib.
Groups 4 and 5 will include patients positive for the PD-L1 protein. Group 4 will receive atezolizumab, ipatasertib, and paclitaxel. Group 5 will receive atezolizumab, paclitaxel, and a placebo in place of ipatasertib.
Patients will be treated on 28-day cycles. Follow-up will be up to 76 months and the outcomes evaluated will be survival without disease worsening, overall survival, response to treatment, and patient quality of life.