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| Name | Class |
|---|---|
| Korean Breast Cancer Study Group | OTHER |
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The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel lymph node biopsy | Placebo Comparator | Perform conventional sentinel lymph biopsy |
|
| Adjuvant radiation without Sentinel lymph node biopsy | Experimental | Perform radiotherapy instead of sentinel lymph node biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Procedure | Adjuvant radiotherapy on axillary region |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Disease free survival including breast, axilla and other organs from medical record | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence | Ipsilateral breast from medical record | 5 years |
| Axillary recurrence | Ipsilateral axillary lymph nodes from medical record |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life by questionnaire | Pain, Discomfort, Numbness, Rotation of arm, Lymphedema of arm | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008207 | Lymphatic Metastasis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 5 years |
| distant recurrence | Other organs except ipsilateral breast and axillary lymph nodes from medical record | 5 years |
| distant free survival | No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record | 5 years |
| Overall survival | Overall survival from medical record | 5 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |