An Open-label Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in Patients With HER2-negative Breast Cancer
This is a prospective, single-center, open-label phase II clinical trial investigating the
activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC
candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour
volume at the end of EndoTAG-1 + paclitaxel administration. Patients will be stratified by
hormone receptor status.
A total of 20 female patients with non-metastatic HER2-negative breast cancer candidate for
neoadjuvant chemotherapy and meeting all study eligibility criteria will receive 12 weekly
infusions of EndoTAG-1 (22 mg/m2 liposomal paclitaxel) in combination with paclitaxel (70
mg/m2) followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2,
Cyclophosphamide 500mg/m2) every 3 weeks (experimental group) The study hypothesis is that
EndoTAG-1 will improve MRI- estimated volume reduction when added to weekly paclitaxel. The
null hypothesis is that combination has no or a negligible effect on volume reduction
(defined as lower or equal to a 50% decrease) versus the alternative hypothesis that the
combination yields at least a 80% average decrease in MRI- estimated volume at the end of
weekly paclitaxel and EndoTAG-1 administration from baseline
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
To investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
15 weeks after start of neoadjuvant chemotherapy.
Michail Ignatiadis, MD, PhD
Institut Jules Bordet
Belgium: Federal Agency for Medicinal Products and Health Products