SAKK 24/14: Anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative EGFR positive breast cancer – A multicenter single arm phase II trial
Ongoing - recruitment active · 2016 until 2023
Advanced triple negative breast cancer (TNBC) is a highly chemosensitive disease displaying a dismal short-term prognosis with more than three quarters of patients in pro-gression 12 months after the initiation of conventional chemotherapy. Approximately 2/3 of TNBC are expressing EGFR. Breast cancer, including TNBC, is a disease highly sensitive to anthracylines. Data from a phase I trial, in 26 patients with different solid tumors, show very little toxicity and signs of efficacy of anti-EGFR-IL-dox. The main objec-tive of the trial is to determine the efficacy of anti-EGFR-IL-dox as first-line therapy in patients with advanced triple negative EGFR positive breast cancer. The primary end-point of the trial is: Progression-free survival at 12 months Secondary endpoints of the trial are: Objective response rate, Duration of response, Time to progression, Progres-sion-free survival, Overall survival, Adverse events.