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Phase II Single Arm Study evaluating safety, feasibility and efficacy of Ipilimumab and Nivolumab with neoadjuvant weekly Paclitaxel after Anthracycline based chemotherapy in High-risk primary Triple Negative Breast Cancer, followed by definite surgery and completion of 1 year total duration of Nivolumab
Australian New Zealand Breast Cancer Trials Group (ANZBCTG)
Before surgery, patients will receive the following treatments, simultaneously, over a 12 week period -
Intravenous Nivolumab at 3mg/kg every 2 weeks for 6 doses; Intravenous Ipilimumab at 1mg/kg every 6 weeks for 2 doses; and Intravenous Paclitaxel at 80mg/m^2 for 12 doses. Where administration of the study drugs occur on the same day, Nivolumab is given first, Ipilimumab second and Paclitaxel last.
Surgery will take place within 4 weeks of the last paclitaxel dose.
Participants will recommence Nivolumab 2-6 weeks after surgery as determined by the investigator.