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.

Abstract

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.

CLINICAL TRIAL REGISTRATION:

https://clinicaltrials.gov/ (NCT03515798).

• Authors: Alexandre Bertucci, François Bertucci, Christophe Zemmour, Florence Lerebours, Jean-Yves Pierga, Christelle Levy, Florence Dalenc, Julien Grenier, Thierry Petit, Marguerite Berline, Anthony Gonçalves
• Journal: Frontiers in oncology (Front Oncol) Vol. 10 Pg. 575978 ( 2020) ISSN: 2234-943X [Print] Switzerland
• PMID: 33330051 (Publication Type: Journal Article)
• Copyright: Copyright © 2020 Bertucci, Bertucci, Zemmour, Lerebours, Pierga, Levy, Dalenc, Grenier, Petit, Berline and Gonçalves.