Project Description:
A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study to Compare the Efficacy and Safety of Hercules Versus Herceptin® in Patients with HER2+Metastatic Breast Cancer. Primary objective is to compare the effect of Hercules vs. Herceptin on the over-all tumor response, both in comb . . .
Key Inclusion and Exclusion Criteria:
Inclusion criteria: 1. Female ≥ 18 years of age. 2. Pathologically confirmed, uni-dimensionally measurable MBC lesion (based on Response Evaluation Criteria in Solid Tumor [RECIST] criteria, version 1.1). Measurable lesion is defined as a visceral lesion at least 10 mm in longest diameter or lymph . . .
Countries of Recruitment:
Belarus, Bosnia and Herzegovina, Bulgaria, Czech Republic, Egypt, Georgia, Germany, Hungary, India, Morocco, Philippines, Poland, Romania, Russia, Serbia and Montenegro, Slovakia, South Africa, Thailand, Tunisia, Turkey, Ukraine, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom