This trial is examining the effectiveness of chemotherapy and atezolizumab (Tecentriq), given before surgery, for triple negative breast cancer. The main outcomes to be measured will be response in the breast tissue and lymph nodes and survival.
Triple negative breast cancer is not dependent on the HER2 receptors or hormones for growth. Usually, after neoadjuvant therapy (treatment given before surgery) and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. 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 before surgery for breast cancer plus atezolizumab is more effective than the usual chemotherapy plus a placebo (substance with no active effect).This study will also look at continuing treatment after surgery with atezolizumab or the placebo. 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 1520 patients with triple-negative breast cancer. Patients should have normal blood counts, 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), autoimmune disorders, tuberculosis, uncontrolled high blood pressure, gastrointestinal disorders, or cardiovascular disease. Patients should not have had surgery to investigate their breast cancer. Participants should not have undergone a stem cell transplantation.
How will it work
Patients will be randomly assigned to one of two groups. Both groups will receive the usual chemotherapy. One group will receive atezolizumab while the other will receive a placebo. Both will be delivered through an IV (directly into a vein). The usual chemotherapy in this study is paclitaxel and carboplatin followed by doxorubicin and cyclophosphamide or epirubicin and cyclophosphamide. Patients will then undergo surgery, followed by 6 months of treatment with either atezolizumab or placebo.
Patients will be followed up for up to five years or more.