search
Back to results

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

Primary Purpose

Breast Neoplasm Female, Lymphatic Metastasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Kyungpook National University Chilgok Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm Female focused on measuring Breast cancer, cN1, ycN0, Neoadjuvant cheotherapy, Sentinel Lymph Node, Radiotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Sentinel lymph node biopsy

    Adjuvant radiation without Sentinel lymph node biopsy

    Arm Description

    Perform conventional sentinel lymph biopsy

    Perform radiotherapy instead of sentinel lymph node biopsy

    Outcomes

    Primary Outcome Measures

    Disease-free survival
    Disease free survival including breast, axilla and other organs from medical record

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 1, 2019
    Last Updated
    October 2, 2019
    Sponsor
    Kyungpook National University Chilgok Hospital
    Collaborators
    Korean Breast Cancer Study Group
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04116125
    Brief Title
    Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kyungpook National University Chilgok Hospital
    Collaborators
    Korean Breast Cancer Study Group

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasm Female, Lymphatic Metastasis
    Keywords
    Breast cancer, cN1, ycN0, Neoadjuvant cheotherapy, Sentinel Lymph Node, Radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1380 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sentinel lymph node biopsy
    Arm Type
    Placebo Comparator
    Arm Description
    Perform conventional sentinel lymph biopsy
    Arm Title
    Adjuvant radiation without Sentinel lymph node biopsy
    Arm Type
    Experimental
    Arm Description
    Perform radiotherapy instead of sentinel lymph node biopsy
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiotherapy
    Intervention Description
    Adjuvant radiotherapy on axillary region
    Primary Outcome Measure Information:
    Title
    Disease-free survival
    Description
    Disease free survival including breast, axilla and other organs from medical record
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Local recurrence
    Description
    Ipsilateral breast from medical record
    Time Frame
    5 years
    Title
    Axillary recurrence
    Description
    Ipsilateral axillary lymph nodes from medical record
    Time Frame
    5 years
    Title
    distant recurrence
    Description
    Other organs except ipsilateral breast and axillary lymph nodes from medical record
    Time Frame
    5 years
    Title
    distant free survival
    Description
    No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record
    Time Frame
    5 years
    Title
    Overall survival
    Description
    Overall survival from medical record
    Time Frame
    5 years
    Other Pre-specified Outcome Measures:
    Title
    Quality of life by questionnaire
    Description
    Pain, Discomfort, Numbness, Rotation of arm, Lymphedema of arm
    Time Frame
    5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs