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Chemotherapy Adriamycin+Cyclophosphamide\>Docetaxel

Endocrine therapy(GnRHa with Tamoxifen) group

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

Adriamycin+Cyclophosphamide>Docetaxel

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

GnRHa with Tamoxifen

Ahn Sei Hyun, MD.PhD

Ahn Sei Hyun, M.D.

A. S. Hyun, MD.PhD

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

Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

Korean Breast Cancer Study Group

Asan Medical Center

M.D., Ph.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer	NCT01622361	Breast Cancer	Adriamycin+Cycl... GnRHa with Tamo...	20 Years -	Asan Medical Center
Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer	NCT01622361	Breast Cancer	Adriamycin+Cycl... GnRHa with Tamo...	20 Years -	Asan Medical Center

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