The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2 negative, lymph node positive, primary breast cancer in premenopausal women.
1. Primary objective : Response Rate-MRI and/or Caliper 2. Secondary objectives * Pathologic complete response * Rate of conservation surgery * Ki-67 changes and its relationship to treatment response * Length of time to maximum response within the treatment period * Tolerability of two treatments * Disease-free survival(DFS) * Overall survival
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
1. Adriamycin 60mg/m2 + Cyclophosphamide 600mg/m2 * Route: by slow intravenous bolus * Schedule: every 3weeks for 4 cycle 2. Docetaxel 75mg/m2 * Route: intravenous as per local practice * Schedule: every 3weeks for 4 cycle
1. Goserelin(GnRHa) 3.6mg * Route: subcutaneously under the abdominal skin * Schedule: every 4weeks for 6cycles (period of 34 days between 2 administrations must not be exceeded) 2. Tamoxifen 20mg/day * Route: Oral * Schedule: everyday
Asan Medical Center
Seoul, Songpa-gu, South Korea
RECRUITINGResponse Rate
Time frame: 6 months
Pathologic complete response
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.