Breast Neoplasm Female Clinical Trial
— OBSERBOfficial title:
A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer
Verified date | October 2019 |
Source | Kyungpook National University Chilgok Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
Status | Not yet recruiting |
Enrollment | 1380 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kyungpook National University Chilgok Hospital | Korean Breast Cancer Study Group |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life by questionnaire | Pain, Discomfort, Numbness, Rotation of arm, Lymphedema of arm | 5 years | |
Primary | Disease-free survival | Disease free survival including breast, axilla and other organs from medical record | 5 years | |
Secondary | Local recurrence | Ipsilateral breast from medical record | 5 years | |
Secondary | Axillary recurrence | Ipsilateral axillary lymph nodes from medical record | 5 years | |
Secondary | distant recurrence | Other organs except ipsilateral breast and axillary lymph nodes from medical record | 5 years | |
Secondary | distant free survival | No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record | 5 years | |
Secondary | Overall survival | Overall survival from medical record | 5 years |
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