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| Name | Class |
|---|---|
| Korean Breast Cancer Study Group | OTHER |
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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.
Primary objective
: Response Rate-MRI and/or Caliper
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy Group | Active Comparator | Chemotherapy Adriamycin+Cyclophosphamide>Docetaxel |
|
| Endocrine therapy group | Experimental | Endocrine therapy(GnRHa with Tamoxifen) group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adriamycin+Cyclophosphamide>Docetaxel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response | 6 months |
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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 :
over 20 years old
Pre-treatment haematology and biochemistry values within acceptable limits :
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:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahn Sei Hyun, MD.PhD | Contact | 82-2-3010-3490 | ahnsh@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34660302 | Derived | 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. | |
| 34277393 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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|
|
| GnRHa with Tamoxifen | Drug |
|
|
|
| Derived |
| 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. |
| 32460816 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |