Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer (NEST)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adriamycin+Cyclophosphamide>Docetaxel
GnRHa with Tamoxifen
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Neoadjuvant, endocrine therapy, premenopausal, hormone responsive, HER2 negative, lymph node positive
Eligibility Criteria
Inclusion Criteria:
- Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
- Pathologically proven lymph node positive tumor(FNAB or Core biopsy)
- 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)
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
- over 20 years old
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
- ECOG PS of 0 or 1
- No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
- Before any study-specific procedures, the appropriate written informed consent must be obtained
Exclusion Criteria:
- Inflammatory breast cancer
- Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
- Known severe hypersensitivity to GnRHa treatment
- Bilateral invasive breast cancer
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
- HRT within 4 weeks of starting treatment
- Definite contra-indications for the use of corticosteroids.
- 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)
- Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
- Pregnant or breastfeeding women
- Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chemotherapy Group
Endocrine therapy group
Arm Description
Chemotherapy Adriamycin+Cyclophosphamide>Docetaxel
Endocrine therapy(GnRHa with Tamoxifen) group
Outcomes
Primary Outcome Measures
Response Rate
Secondary Outcome Measures
Pathologic complete response
Full Information
NCT ID
NCT01622361
First Posted
June 13, 2012
Last Updated
September 26, 2013
Sponsor
Asan Medical Center
Collaborators
Korean Breast Cancer Study Group
1. Study Identification
Unique Protocol Identification Number
NCT01622361
Brief Title
Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
Acronym
NEST
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Korean Breast Cancer Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Primary objective
: Response Rate-MRI and/or Caliper
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Neoadjuvant, endocrine therapy, premenopausal, hormone responsive, HER2 negative, lymph node positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy Group
Arm Type
Active Comparator
Arm Description
Chemotherapy Adriamycin+Cyclophosphamide>Docetaxel
Arm Title
Endocrine therapy group
Arm Type
Experimental
Arm Description
Endocrine therapy(GnRHa with Tamoxifen) group
Intervention Type
Drug
Intervention Name(s)
Adriamycin+Cyclophosphamide>Docetaxel
Other Intervention Name(s)
Chemotherapy
Intervention Description
Adriamycin 60mg/m2 + Cyclophosphamide 600mg/m2
Route: by slow intravenous bolus
Schedule: every 3weeks for 4 cycle
Docetaxel 75mg/m2
Route: intravenous as per local practice
Schedule: every 3weeks for 4 cycle
Intervention Type
Drug
Intervention Name(s)
GnRHa with Tamoxifen
Other Intervention Name(s)
Endocrine Therapy
Intervention Description
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)
Tamoxifen 20mg/day
Route: Oral
Schedule: everyday
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pathologic complete response
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
Pathologically proven lymph node positive tumor(FNAB or Core biopsy)
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)
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
over 20 years old
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
ECOG PS of 0 or 1
No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
Before any study-specific procedures, the appropriate written informed consent must be obtained
Exclusion Criteria:
Inflammatory breast cancer
Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
Known severe hypersensitivity to GnRHa treatment
Bilateral invasive breast cancer
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
HRT within 4 weeks of starting treatment
Definite contra-indications for the use of corticosteroids.
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)
Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
Pregnant or breastfeeding women
Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahn Sei Hyun, MD.PhD
Phone
82-2-3010-3490
Email
ahnsh@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahn Sei Hyun, M.D.
Phone
82-2-3010-3490
Email
ahnsh@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
A. S. Hyun, MD.PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34660302
Citation
Gwark S, Noh WC, Ahn SH, Lee ES, Jung Y, Kim LS, Han W, Nam SJ, Gong G, Kim SO, Kim HJ. Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer. Front Oncol. 2021 Sep 30;11:741120. doi: 10.3389/fonc.2021.741120. eCollection 2021.
Results Reference
derived
PubMed Identifier
34277393
Citation
Gwark S, Ahn SH, Noh WC, Lee ES, Jung Y, Kim LS, Han W, Nam SJ, Gong G, Kim SO, Kim HJ. Patient-Reported Outcomes From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer. Front Oncol. 2021 Jul 2;11:608207. doi: 10.3389/fonc.2021.608207. eCollection 2021.
Results Reference
derived
PubMed Identifier
32460816
Citation
Kim HJ, Noh WC, Lee ES, Jung YS, Kim LS, Han W, Nam SJ, Gong G-, Kim HJ, Ahn SH. Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer. Breast Cancer Res. 2020 May 27;22(1):54. doi: 10.1186/s13058-020-01288-5.
Results Reference
derived
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Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
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