Breast Neoplasm Female, Lymphatic Metastasis
Conditions
Keywords
Breast cancer, cN1, ycN0, Neoadjuvant cheotherapy, Sentinel Lymph Node, Radiotherapy
Brief summary
The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
Detailed description
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.
Interventions
PROCEDURERadiotherapy
Adjuvant radiotherapy on axillary region
Sponsors
Korean Breast Cancer Study Group
Kyungpook National University Chilgok Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. women aged \> 20 years 2. cT1-3N1M0, primary invasive 3. initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy 4. completion of neoadjuvant chemotherapy 5. tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy
Exclusion criteria
1. synchronous distant metastases 2. previous other malignancy 3. bilateral breast cancer 4. previous primary systemic therapy 5. pregnancy or breastfeeding 6. pre-operative radiological evidence of multiple involved or suspicious axillary nodes 7. patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 5 years | Disease free survival including breast, axilla and other organs from medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence | 5 years | Ipsilateral breast from medical record |
| Axillary recurrence | 5 years | Ipsilateral axillary lymph nodes from medical record |
| distant free survival | 5 years | No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record |
| Overall survival | 5 years | Overall survival from medical record |
| distant recurrence | 5 years | Other organs except ipsilateral breast and axillary lymph nodes from medical record |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life by questionnaire | 5 years | Pain, Discomfort, Numbness, Rotation of arm, Lymphedema of arm |
Outcome results
None listed