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

This study is currently recruiting participants.
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

June 13, 2012
September 26, 2013
June 2012
February 2016   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01622361 on ClinicalTrials.gov Archive Site
Pathologic complete response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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
  • Active Comparator: Chemotherapy Group
    Chemotherapy Adriamycin+Cyclophosphamide>Docetaxel
    Intervention: Drug: Adriamycin+Cyclophosphamide>Docetaxel
  • Experimental: Endocrine therapy group
    Endocrine therapy(GnRHa with Tamoxifen) group
    Intervention: Drug: GnRHa with Tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
February 2016
February 2016   (final data collection date for primary outcome measure)

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).
Female
20 Years and older
No
Contact: Ahn Sei Hyun, MD.PhD 82-2-3010-3490 ahnsh@amc.seoul.kr
Korea, Republic of
 
NCT01622361
KBCSG012
Yes
Sei-Hyun Ahn, Asan Medical Center
Asan Medical Center
Korean Breast Cancer Study Group
Not Provided
Asan Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP