Status:
UNKNOWN
Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial
Lead Sponsor:
Kyungpook National University Chilgok Hospital
Collaborating Sponsors:
Korean Breast Cancer Study Group
Conditions:
Breast Neoplasm Female
Lymphatic Metastasis
Eligibility:
FEMALE
20+ years
Phase:
NA
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 wa...
Eligibility Criteria
Inclusion
- women aged \> 20 years
- cT1-3N1M0, primary invasive
- initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy
- completion of neoadjuvant chemotherapy
- tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy
Exclusion
- synchronous distant metastases
- previous other malignancy
- bilateral breast cancer
- previous primary systemic therapy
- pregnancy or breastfeeding
- pre-operative radiological evidence of multiple involved or suspicious axillary nodes
- patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
1380 Patients enrolled
Trial Details
Trial ID
NCT04116125
Start Date
July 1 2020
End Date
June 30 2025
Last Update
October 4 2019
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