Eine prospektive, multizentrische, offene, neoadjuvante einarmige Phase-II-Studie mit Pembrolizumab in Kombination mit dualer Anti-HER2-Blockade mit Trastuzumab und Pertuzumab bei Brustkrebspatientinnen im Frühstadium mit molekularem HER2-angereichertem intrinsischem Subtyp
Trial treatment is defined as neoadjuvant therapy only. Investigational Medicinal Products (IMPs) are pembrolizumab (Keytruda®, Merck/MSD), trastuzumab biosimilar ABP 980 (Kanjinti®, Amgen) and pertuzumab (Perjeta®, Roche). Pembrolizumab, trastuzumab biosimilar ABP 980 and pertuzumab will be labeled study-specifically. Documentation of preparation and distribution of pembrolizumab has to be recorded in accordance with the Investigator’s Brochure and of the trastuzumab biosimilar ABP 980 and pertuzumab according to the Summary of product characteristics (SmPC).
