Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bone Density Conservation Agents

Anti-Infective Agents

Docetaxel

Cyclophosphamide

Tamoxifen

Hormones

Goserelin

Doxorubicin

Liposomal doxorubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

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

Spots Global Cancer Trial Database for gnrha with tamoxifen