This trial is examining the effectiveness of atezolizumab(Tecentriq) when used with chemotherapy in patients with inoperable, recurrent triple-negative breast cancer. The main outcome to be measured will be the overall survival (time from treatment until death from any cause) of participants.
Triple negative breast cancer is not dependent on the HER2 receptors or hormones for growth. Because there are no receptors to target for treatment, other therapies are needed. Atezolizumab is a type of treatment that may stimulate the immune system to fight against the cancer.
The main purpose of this study is to learn if the usual chemotherapy given plus atezolizumab is more effective than the usual chemotherapy plus a placebo (substance with no active effect).The main outcomes to be studied include tumor response, survival and progression rates, and side effects.
Who are they looking for?
This study is recruiting 350 patients with triple-negative breast cancer that has recurred in the same area, has spread beyond the breast (metastatic), or cannot be surgically removed. Patients should have normal blood counts, and liver and kidney function. Patients should use contraception during this trial, if pre-menopausal.
Patients should not have active infections (including HIV and hepatitis B), brain metastases, uncontrolled high blood pressure, gastrointestinal disorders, or cardiovascular disease. Participants will be excluded if they have autoimmune disease or have undergone stem cell transplantation. Patients should not have received treatment for their recurrent cancer but previous radiation therapy to the site of recurrence is acceptable.
How will it work
Patients will be randomly assigned to one of two groups. Both groups will receive the usual chemotherapy (gemcitabine, capecitabine, and carboplatin). One group will receive atezolizumab while the other will receive a placebo.
Participants will be followed up for a year or more.