PELICAN-IPC 2015-016/Oncodistinct-003: A Prospective, Multicenter, Open-Label, Randomized, Non-Comparative, Phase II Study of Pembrolizumab in Combination With Neo Adjuvant EC-Paclitaxel Regimen in HER2-Negative Inflammatory Breast Cancer

• Published in: Frontiers in oncology Vol. 10; p. 575978
• Main Authors: Bertucci, Alexandre, Bertucci, François, Zemmour, Christophe, Lerebours, Florence, Pierga, Jean-Yves, Levy, Christelle, Dalenc, Florence, Grenier, Julien, Petit, Thierry, Berline, Marguerite, Gonçalves, Anthony
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media 25.11.2020; Frontiers Media S.A
• Subjects: Cancer; immune checkpoint inhibitor; inflammatory breast cancer; Life Sciences; neoadjuvant therapy; Oncology; PDL1; pembrolizumab; pembrolizumab; immune checkpoint inhibitor; inflammatory breast cancer; PDL1; neoadjuvant therapy
• ISSN: 2234-943X; 2234-943X
• DOI: 10.3389/fonc.2020.575978

Inflammatory breast cancer (IBC) is a highly aggressive entity with a poor outcome and relative resistance to treatment. Despite progresses achieved during the last decades, the survival remains significantly lower than non-IBC. Recent clinical trials assessing PD-1/PD-L1 inhibitors showed promising results in non-IBC. Pembrolizumab, an anti-PD-1 monoclonal antibody, revolutionized the treatment of different cancers. Several recent studies suggested a potential interest of targeting the immune system in IBC by revealing a more frequent PD-L1 expression and an enriched immune microenvironment when compared with non-IBC. Here, we describe the rationale and design of PELICAN-IPC 2015-016/Oncodistinct-003 trial, an open-label, randomized, non-comparative, phase II study assessing efficacy, and safety of pembrolizumab in combination with anthracycline-containing neoadjuvant chemotherapy in HER2-negative IBC. The trial is ongoing. The primary endpoint is the pCR rate (ypT0/Tis, ypN0) in overall population and the co-primary endpoint is safety profile during a run-in phase. Key secondary objectives include tolerability, invasive disease-free, event-free and overall survivals, as well as collection of tumor and blood samples for translational research. https://clinicaltrials.gov/ (NCT03515798).