This study will examine how safe and effective the medication atezolizumab (Tecentriq) is in combination with other anti-cancer medicines for treating early stage HER2+ breast cancer. The main outcome that will be measured is how many patients completely respond to treatment, with no trace of the cancer remaining.
The details
Atezolizumab is a new anti-cancer medication. It works by targeting the immune system to kill the cancer cells. It is designed to work with other anti-cancer medications. It is not known if treating patients with atezolizumab alongside other anti-cancer medications will be better than just using the standard treatment.
This study will examine how safe and effective the medication atezolizumab is in combination with other anti-cancer medicines for treating early-stage HER2+ breast cancer. The main outcome that will be measured is how many patients completely respond to treatment, with no trace of the cancer remaining.
Who are they looking for?
This trial is recruiting 224 patients with HER2-positive breast cancer with a tumor larger than 2 cm. The patients must have adequate organ function, and heart function.
The patients must not be planning to get pregnant soon. Patients cannot have been previously treated for any kind of cancer. Patients will be excluded from the study if they have any immune system issues, cancer spread to other organs, heart disease, removed lymph nodes or an ulceration of the breast.
How will it work
The patients will be split into two groups. Patients in both groups will recieve standard treatment for HER2+ breast cancer. This is a combination of a number of drugs and is called ddAC-PacHP (doxorubicin, cyclophosphamide, paclitaxel, trastuzumab, and pertuzumab). The patients in the first group will also be treated with atezolizumab. Patients in the second group will be treated with a placebo.
The patients will be randomly allocated to the groups. The trial will end 48 months after treatment begins.
