A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer
Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer,
and this method of treatment has been extended to patients with earlier disease without
affecting the treatment outcome. This single arm, multicenter phase II study was designed to
evaluate the response rate, toxicity, progression free survival and tumor control rate of
docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate was assessed by pathologic examination after surgery.
Young Jin Suh, M.D. Ph.D
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
Korea: Food and Drug Administration