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Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Internal mammary node irradiation
No internal mammary node irradiation
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

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

Inclusion Criteria:

1. Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed.

Exclusion Criteria:

  1. Neoadjuvant chemotherapy
  2. Bilateral breast cancer
  3. Distant metastasis
  4. History of other malignancy
  5. Involvement of supraclavicular nodes or internal mammary nodes at diagnosis

Sites / Locations

  • Yonsei Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internal mammary node irradiation

No internal mammary node irradiation

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Rates of overall survival
breast cancer-specific survival
Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3

Full Information

First Posted
March 9, 2021
Last Updated
March 16, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04803266
Brief Title
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer
Official Title
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2008 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.
Detailed Description
This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
747 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal mammary node irradiation
Arm Type
Experimental
Arm Title
No internal mammary node irradiation
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Internal mammary node irradiation
Intervention Description
Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
Intervention Type
Radiation
Intervention Name(s)
No internal mammary node irradiation
Intervention Description
Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Rates of overall survival
Time Frame
7 years
Title
breast cancer-specific survival
Time Frame
7 years
Title
Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3
Time Frame
7 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed. Exclusion Criteria: Neoadjuvant chemotherapy Bilateral breast cancer Distant metastasis History of other malignancy Involvement of supraclavicular nodes or internal mammary nodes at diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Bae Kim, MD, PhD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Analytic codes will be shared upon reasonable request to corresponding author.
Citations:
PubMed Identifier
34695841
Citation
Kim YB, Byun HK, Kim DY, Ahn SJ, Lee HS, Park W, Kim SS, Kim JH, Lee KC, Lee IJ, Kim WT, Shin HS, Kim K, Shin KH, Nam CM, Suh CO. Effect of Elective Internal Mammary Node Irradiation on Disease-Free Survival in Women With Node-Positive Breast Cancer: A Randomized Phase 3 Clinical Trial. JAMA Oncol. 2022 Jan 1;8(1):96-105. doi: 10.1001/jamaoncol.2021.6036.
Results Reference
derived

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Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer

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