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

September 26, 2013 updated by: Sei-Hyun Ahn, Asan Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • A. S. Hyun, MD.PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Endocrine Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pathologic complete response
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korean Breast Cancer Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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