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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.

Paclitaxel

Albumin-Bound Paclitaxel

Lenograstim

Adriamycin

cyclophosphamide

G-CSF

paclitaxel

This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.

This is a pilot feasibility trial of AC (Adriamycin® (Registered Trademark), cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol® (Registered Trademark) (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.

A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients	NCT00001384	Breast Cancer Breast Neoplasm...	Adriamycin cyclophosphamid... G-CSF paclitaxel	-	National Institutes of Health Clinical Center (CC)
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 lymph node positive