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

 1. Histologically proven primary invasive breast cancer which is thought to be suitable
 for neo-adjuvant treatment

 2. Pathologically proven lymph node positive tumor(FNAB or Core biopsy)

 3. Tumor must be ER positive(eligible patients include Allred score 5 and more, Modified
 Allred 4 and more) and HER-2 negative(IHC score is 0-1+; If IHC score is 2+, the
 result of FISH or SISH is negative)

 4. Premenopausal women

 Premenopausal status as defined by :

 -  Last menses within 6 month of randomization or

 -  For patients who have had a unilateral oophorectomy, E2 ≥ 20PG/mL and FSH <
 30mIU/Ml within 4 weeks of randomization

 5. over 20 years old

 6. Pre-treatment haematology and biochemistry values within acceptable limits :

 -  ANC ≥ 1.5 × 109/l

 -  Hb > 9g/dl

 -  Platelets ≥ 100 × 109/l

 -  AST/ALT ≤ 1.5 × ULN(Upper Limit of Normal)

 -  ALP ≤ 1.5 × ULN

 -  Serum bilirubin ≤ 1.5 × ULN

 -  Serum creatinine ≤ 1.5 × ULN

 7. ECOG PS of 0 or 1

 8. No concomitant medical, psychiatric or geographic problems that might prevent
 completion of treatment or follow-up

 9. Before any study-specific procedures, the appropriate written informed consent must be
 obtained

 Exclusion Criteria:

 1. Inflammatory breast cancer

 2. Inoperable disease that is judged very unlikely to be rendered operable by
 neo-adjuvant treatment

 3. Known severe hypersensitivity to GnRHa treatment

 4. Bilateral invasive breast cancer

 5. Other serious illness or medical condition:

 -  congestive heart failure or unstable angina pectoris, previous history of
 myocardial infarction within 1 year from study entry, uncontrolled hypertension
 or high-risk uncontrolled arrhythmias

 -  history of significant neurologic or psychiatric disorders including psychotic
 disorders, dementia or seizures that would prohibit the understanding and giving
 of informed consent

 -  active uncontrolled infection

 6. HRT within 4 weeks of starting treatment

 7. Definite contra-indications for the use of corticosteroids.

 8. Last 10 years with a history of other malignant tumor (except in the case of basal
 cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of
 resection)

 9. Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the
 guideline in each institution)

 10. Pregnant or breastfeeding women

 11. Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study
 entry and at low dose (≤ 20 mg methylprednisolone or equivalent).