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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01622361
Recruitment Status : Unknown
Verified September 2013 by Sei-Hyun Ahn, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : September 30, 2013
Korean Breast Cancer Study Group
Information provided by (Responsible Party):
Sei-Hyun Ahn, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Adriamycin+Cyclophosphamide>Docetaxel Drug: GnRHa with Tamoxifen Phase 3

Detailed Description:
  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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tamoxifen

Arm Intervention/treatment
Active Comparator: Chemotherapy Group
Chemotherapy Adriamycin+Cyclophosphamide>Docetaxel
Drug: Adriamycin+Cyclophosphamide>Docetaxel
  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
Other Name: Chemotherapy

Experimental: Endocrine therapy group
Endocrine therapy(GnRHa with Tamoxifen) group
Drug: GnRHa with Tamoxifen
  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
Other Name: Endocrine Therapy

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pathologic complete response [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01622361

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Contact: Ahn Sei Hyun, MD.PhD 82-2-3010-3490

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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Ahn Sei Hyun, M.D.    82-2-3010-3490   
Principal Investigator: A. S. Hyun, MD.PhD         
Sponsors and Collaborators
Asan Medical Center
Korean Breast Cancer Study Group
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sei-Hyun Ahn, M.D., Ph.D., Asan Medical Center Identifier: NCT01622361    
Other Study ID Numbers: KBCSG012
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013
Keywords provided by Sei-Hyun Ahn, Asan Medical Center:
endocrine therapy
hormone responsive
HER2 negative
lymph node positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal