A phase II study evaluating efficacy and safety of Ipilimumab and Nivolumab with neoadjuvant weekly paclitaxel after anthracycline based chemotherapy in high-risk primary triple negative breast cancer, followed by definitive surgery and one year total duration of Nivolumab (BCT 1702 CHARIOT)

Full description

* Dataset of 34 patients with high risk primary triple negative breast cancer suitable for neoadjuvant treatment after treatment with 4 cycles anthracycline-based chemotherapy. * Study treatment for 12 weeks with Nivolumab for 6 doses; Ipilimumab for 2 doses; paclitaxel weekly for 12 doses. * Surgery withn 4 weeks of last paclitaxel dose. * Followed by nivolumab every 4 weeks for up to 1 year. * Survival follow up at 24 months and 36 months from cycle 1 day 1. * pCR, residual diseae, objective response rate data. * Safety/toxicity, event free survival, overall survival data. * ctDNA data. Cancer Australia demographic data has been collected including: Postcode of usual residence, Indigenous status, CALD status (Country of Birth, Main language other than English used as the principle means of communication).

Notes

HeSANDA 1.0.0