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
Adriamycin+Cyclophosphamide>Docetaxel
+ GnRHa with Tamoxifen
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.290 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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