Inflammatory Breast Cancer Clinical Trial
Official title:
A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.
This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.
Inflammatory breast cancer (IBC) is a rare and highly aggressive subtype of locally advanced
breast cancer representing approximately 5% of all breast cancers that requires immediate
aggressive treatment. Significant progress has been made in recent years using a combination
of treatments, including neoadjuvant chemotherapy, surgery and radiation therapy.
Accumulating data indicate a prognostic and/or predictive impact for immune-response
variables in BC. Recent data, suggest that PD-L1 is overexpressed in a significant number of
BC, notably in IBC and may have significant prognostic or predictive value. Furthermore it
may be targeted to restore or boost functional antitumor immunity. Pembrolizumab, a
PD-1-directed monoclonal antibody is already registered and has an out-standing activity in
advanced melanoma and NSCLC patients, with promising results in several other tumor types,
including triple-negative BC, and a favorable profile of tolerance.
Thus, potential benefits of pembrolizumab in combination with a conventional cytotoxic
backbone may be considered as high in HER2-negative IBC.
The aim of the study is to assess the pathological complete response rate following
neoadjuvant EC-paclitaxel chemotherapy plus pembrolizumab and to assess if neoadjuvant
chemotherapy with anthracycline-based induction in combination with pembrolizumab exposes IBC
patients to significant toxicity. rates.
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