Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-01

Summary

The purpose of the study is to address the following hypotheses: (i) Anti-PD-L1 therapy with MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736 concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete response (pCR) rate (>55%) in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone. (ii) MEDI4736 can be safely co-administered at full dose with sequential with nab-paclitaxel (100mg/m2) and ddAC (60 mg/m2 and 600 mg/m2 respectively).

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Yale University
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Cyclophosphamide; Doxorubicin; Durvalumab; Liposomal doxorubicin; Paclitaxel; Tremelimumab