Trial Information

Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer

This is a multicenter, prospective, randomized, controlled phase Ⅲ clinical trial. A total
of 800 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated
with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be
allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar
or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound
(CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET)
scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary
endpoint is clinical/pathological response. The clinical response will be evaluated
according to RECIST criteria. The parameters of tumor metabolism and blood supply, as
demonstrated by PET, MRA and CEUS, will be collected and analysed. The secondary endpoint is
(1) the number of participants with adverse events, (2) quality of life scores, and (3) the
number of adverse events reported during neoadjuvant therapy. In addition, the role of
mammography, CEUS, MRA and PET for response evaluation, as well as the angiogenic profile
and biological information involved in tumor response will be investigated.