An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Breast cancer is still a major public health problem worldwide, as it is by far the most
frequent neoplasm in women. In recent years so-called "profiling of breast cancer" with
expression arrays has become common and it was suggested that the results will allow
individualization of care. Breast cancer may now be subclassified into luminal, basal, and
HER-2 subtypes with distinct differences in prognosis and response to therapy. About 80% of
all basal-like-breast cancers possess a so-called "triple-receptor-negative" phenotype.
Patients with "triple receptor negative breast cancer" have a complete absence of hormone
receptors incl. HER-2, an aggressive clinical course and a paucity of treatment options. The
only therapeutic option is chemotherapy and in this respect the choice of cytostatic agents
is limited. Against this background, the study tries to find another therapeutic option by
combining a vascular-disrupting activity with the cytostatic effects of paclitaxel in the
study drug EndoTAG-1.
Comparison: EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in
comparison to paclitaxel (control group)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
4-month progression free survival (PFS) rate
Ahmad Awada, Dr.
Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment