Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer
1 other identifier
interventional
747
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2008
CompletedFirst Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMarch 17, 2021
March 1, 2021
14.2 years
March 9, 2021
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
7 years
Secondary Outcomes (3)
Rates of overall survival
7 years
breast cancer-specific survival
7 years
Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3
7 years
Study Arms (2)
Internal mammary node irradiation
EXPERIMENTALNo internal mammary node irradiation
ACTIVE COMPARATORInterventions
Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- Neoadjuvant chemotherapy
- Bilateral breast cancer
- Distant metastasis
- History of other malignancy
- Involvement of supraclavicular nodes or internal mammary nodes at diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei Severance Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 34695841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Bae Kim, MD, PhD
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 17, 2021
Study Start
November 5, 2008
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
March 17, 2021
Record last verified: 2021-03