Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 5:08 AM
Study NCT ID:
NCT04803266
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: