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

Breast Neoplasm Female Clinical Trial

— OBSERB  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04116125
• Other study ID #: 2019-09-023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2019
• Source: Kyungpook National University Chilgok Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Lymphatic Metastasis

Intervention

Procedure:
• Radiotherapy
Adjuvant radiotherapy on axillary region

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kyungpook National University Chilgok Hospital	Korean Breast Cancer Study Group

Outcome

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