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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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