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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Asan Medical Center
Sponsor:
Collaborator:
Korean Breast Cancer Study Group
Information provided by (Responsible Party):
Sei-Hyun Ahn, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01622361
First received: June 13, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Adriamycin+Cyclophosphamide>Docetaxel
Drug: GnRHa with Tamoxifen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pathologic complete response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: June 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622361

Contacts
Contact: Ahn Sei Hyun, MD.PhD 82-2-3010-3490 ahnsh@amc.seoul.kr

Locations
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    ahnsh@amc.seoul.kr   
Principal Investigator: A. S. Hyun, MD.PhD         
Sponsors and Collaborators
Asan Medical Center
Korean Breast Cancer Study Group
  More Information

No publications provided

Responsible Party: Sei-Hyun Ahn, M.D., Ph.D., Asan Medical Center
ClinicalTrials.gov Identifier: NCT01622361     History of Changes
Other Study ID Numbers: KBCSG012
Study First Received: June 13, 2012
Last Updated: September 26, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Asan Medical Center:
Neoadjuvant
endocrine therapy
premenopausal
hormone responsive
HER2 negative
lymph node positive

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Hormones
Liposomal doxorubicin
Tamoxifen
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014