A randomized phase II trial evaluating the efficacy of a nivolumab monotherapy lead in "window" or commencement of nivolumab concurrently with paclitaxel and carboplatin as neoadjuvant therapy in early stage triple negative breast cancers (BCT 1902 Neo-N)

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THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 110 triple negative breast cancer patients in a randomised, non-comparative "pick-the-winner"study. ARM A - Nivolumab window: Nivolumab monotherapy 240 mg IV, 2 weeks later followed by Nivolumab 360 mg IV with Carboplatin AUC5 once every 3 weeks for 4 cycles and Paclitaxel 80 mg/m^2 every week for 12 weeks as an IV infusion administered per institutional guidelines. This will be followed by surgery a minimum of 2 weeks and a maximum of 4 weeks after the last dose of paclitaxel. ARM B - Concurrent Nivolumab: Nivolumab 360 mg IV with Carboplatin AUC5 once every 3 weeks for 4 cycles and Paclitaxel 80 mg/m^2 every week for 12 weeks.12 weeks of concurrent treatment will immediately followed by Nivolumab monotherapy 240 mg IV. Surgery will follow treatment a minimum of 2 weeks and a maximum of 4 weeks later after the last dose of paclitaxel.The two arms are being compared and one arm does not act as a control to the other. pCR rate will be assessed separately in each cohort. 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).

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HeSANDA 1.0.0