Durvalumab (Medi4736) Concurrent With Nab-Paclitaxel And Dose Dense Doxorubicin Cyclophosphamide (Ddac) As Neoadjuvant Therapy For Triple Negative Breast Cancer (Tnbc)

586Background: The goal of this Phase I/II trial is to assess the safety and efficacy of concurrent administration of durvalumab with weekly nab-paclitaxel (100 mg/m2) x 12 followed by dd AC x 4 as neoadjuvant therapy for stage I-III TNBC. The primary efficacy endpoint is pathologic complete response (ypT0 ypN0, pCR). Methods: The Phase I portion of the trial assessed two dose levels of durvalumab; 3 mg/kg and 10 mg/kg iv every 2 weeks in combination with chemotherapy, dose limiting toxicities (DLT) were evaluated over the entire 20 weeks of therapy. The Phase II portion follows Simon’s two step design, with early stopping for futility if u003c 7 patients achieve pCR among the first 22. Results: No DLT were encountered during the Phase I portion of the trial; the 10 mg/kg was recommended as the phase II dose. Thirty-two patients are enrolled in the trial 14 are still receiving therapy, 16 have completed treatment and underwent surgery and 1 patient withdraw consent. Nine patients (56%, 95% CI: 32%-78%) achiev...