Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
NCT ID: NCT01622361
Last Updated: 2013-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
290 participants
INTERVENTIONAL
2012-06-30
2016-02-29
Brief Summary
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Detailed Description
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: 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy Group
Chemotherapy Adriamycin+Cyclophosphamide\>Docetaxel
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
Endocrine therapy group
Endocrine therapy(GnRHa with Tamoxifen) group
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
20 Years
FEMALE
No
Sponsors
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Korean Breast Cancer Study Group
OTHER
Asan Medical Center
OTHER
Responsible Party
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Sei-Hyun Ahn
M.D., Ph.D.
Locations
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Asan Medical Center
Seoul, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Ahn Sei Hyun, M.D.
Role: primary
References
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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.
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.
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.
Other Identifiers
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KBCSG012
Identifier Type: -
Identifier Source: org_study_id