Suspended

NESTA 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

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What is being tested

Adriamycin+Cyclophosphamide>Docetaxel

+ GnRHa with Tamoxifen

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 20 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorAsan Medical Center
Study ContactAhn Sei Hyun, MD.PhD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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

Official TitleA 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
NCT01622361
Principal SponsorAsan Medical Center
Study ContactAhn Sei Hyun, MD.PhD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

290 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Chemotherapy Adriamycin+Cyclophosphamide\>Docetaxel

Group II

Experimental
Endocrine therapy(GnRHa with Tamoxifen) group

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Asan Medical Center

Seoul, South KoreaOpen Asan Medical Center in Google Maps
SuspendedOne Study Center