BCT 1902: Neo-N
Neo-N is an international study conducted by Breast Cancer Trials (BCT), which will enrol a maximum of 108 patients in approximately 24 Hospitals. Neo-N is open to women and men diagnosed with ‘triple negative’ early breast cancer. Triple negative breast cancer is a form of breast cancer lacking three biological receptors targeted by commonly used therapies. The absence of these biological targets can make treatment of triple negative breast cancer challenging. Standard treatment of triple negative breast cancer typically consists of surgery, chemotherapy and usually a course of radiotherapy. Often chemotherapy treatment is given prior to breast surgery (neo-adjuvant chemotherapy) as it is effective in reducing the size of the breast cancer while providing useful information about the effectiveness of the treatment being given.
Researchers are working to identify more effective treatment options for triple negative breast cancer patients. The purpose of this study is to see if using the immunotherapy drug (nivolumab) together with standard chemotherapy (paclitaxel and carboplatin) is safe and effective in treating breast cancer before surgery.
The body’s immune system works to protect against attacked from foreign invaders that have entered the body, like bacteria and viruses. While various components of the immune system will work to fight the foreign invaders, special white blood cells called lymphocyte T-cells will attack the body’s own cells that may have been affected.
Often cancer cells can cause the body to create an immune response resulting in T-cells and other lymphocytes invading the tumour and attack the cancer. Some cancer cells have developed ways of avoiding the body’s immune system and therefore avoiding attack. The cancer cells do this by producing signal proteins that act to block or ‘check’ the immune cells from functioning as they normally would. These avoidance mechanisms are called ‘immune checkpoints’ and one of the best-known immune checkpoints is ‘Programmed Cell Death 1’ or PD-1.
Immunotherapy drugs developed to block these immune checkpoint signals have shown anti-cancer activity across multiple solid tumours such as melanoma and non-small cell lung cancer. One such immunotherapy drug is ‘Nivolumab’, which works by blocking PD-1 signalling.
In this study nivolumab will be given in combination with paclitaxel and carboplatin to treat triple negative breast cancer. Everyone in the study will receive standard chemotherapy and also the immune therapy however participants will have a 50:50 chance (randomly allocated) of receiving an additional immunotherapy dose prior to chemotherapy (‘Lead in’) or an additional immunotherapy dose after chemotherapy (‘Lead out’). Nivolumab is not an approved treatment for early breast cancer in Australia. The study design will help us understand if the nivolumab ‘lead in’ dose can effectively activate the body’s immune response before the addition of chemotherapy. This may contribute to better outcomes and result in a new standard treatment for triple negative breast cancer patients.