Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial

Not Applicable

Not yet recruiting

• Conditions: Lymphatic Metastasis; Breast Neoplasm Female
• Interventions: Procedure: Radiotherapy

• Registration Number: NCT04116125
• Lead Sponsor: Kyungpook National University Chilgok Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04
• Study Start: 2020-07-01
• Primary Completion: 2023-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel lymph node biopsy	Radiotherapy	Perform conventional sentinel lymph biopsy
Adjuvant radiation without Sentinel lymph node biopsy	Radiotherapy	Perform radiotherapy instead of sentinel lymph node biopsy

Primary Outcome Measures

Name	Time	Method
Disease-free survival	5 years	Disease free survival including breast, axilla and other organs from medical record

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Overall survival from medical record
Local recurrence	5 years	Ipsilateral breast from medical record
distant free survival	5 years	No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record
Axillary recurrence	5 years	Ipsilateral axillary lymph nodes from medical record
distant recurrence	5 years	Other organs except ipsilateral breast and axillary lymph nodes from medical record