GeparNuevo

NCT02685059 📎

Regimen

Experimental
Durvalumab 1.5 g Q4W + nab-paclitaxel weekly x 12 weeks, then durvalumab + epirubicin/cyclophosphamide Q2W x 4 cycles, preceded by a 2-week durvalumab window in half the patients.
Control
Placebo + identical nab-paclitaxel/EC chemotherapy backbone.

Population

Early-stage (cT1b-cT4a-d) triple-negative breast cancer, treatment-naive, in the German GBG phase 2 platform.

Key finding

GeparNuevo missed its primary pCR endpoint but showed striking long-term iDFS/OS gains with durvalumab, suggesting IO survival benefit may decouple from pCR. Supportive but not practice-changing.

Source: PMID 31095287

Timeline

  • Publication: 2019 Aug 1

Guideline citations

  • NCCN BREAST