NCT06549920

Brief Summary

The DBCG IMN study is a nationwide prospective population-based cohort study allocating node-positive breast cancer patients with right-sided tumors to internal mammary node irradiation (IMNI) and patients with left-sided tumors to no IMNI.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,630

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
93mo left

Started Jan 2003

Longer than P75 for not_applicable breast-cancer

Status
active not recruiting

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 Progress75%
Jan 2003Jan 2034

Study Start

First participant enrolled

January 1, 2003

Completed
20.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2034

Expected
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

20.9 years

First QC Date

August 8, 2024

Last Update Submit

August 8, 2024

Conditions

Breast Cancer

Keywords

Internal mammary node irradiationNode-positive breast cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Censored at end of study or by emigration.

    15-years.

Secondary Outcomes (2)

  • Breast cancer mortality

    15-years.

  • Distant recurrences

    15-years.

Study Arms (2)

Internal mammary node irradiation

EXPERIMENTAL

Patients with right-sided breast cancer tumors were allocated to internal mammary node irradiation.

Radiation: Internal mammary node irradiation

No internal mammary node irradiation

NO INTERVENTION

Patients with left-sided breast cancer tumors were allocated to no internal mammary node irradiation.

Interventions

Internal mammary node irradiationRADIATION

Irradiation of the internal mammary nodes in intercostal space 1-4.

Also known as: IMNI
Internal mammary node irradiation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy.

You may not qualify if:

  • Prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nielsen AWM, Thorsen LBJ, Ozcan D, Matthiessen LW, Maae E, Milo MLH, Nielsen MH, Tramm T, Overgaard J, Offersen BV; DBCG RT Committee. Internal mammary node irradiation in 4541 node-positive breast cancer patients treated with newer systemic therapies and 3D-based radiotherapy (DBCG IMN2): a prospective, nationwide, population-based cohort study. Lancet Reg Health Eur. 2024 Dec 12;49:101160. doi: 10.1016/j.lanepe.2024.101160. eCollection 2025 Feb.

    PMID: 39810969DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

January 1, 2003

Primary Completion

November 17, 2023

Study Completion (Estimated)

January 1, 2034

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Data may be requested at the DBCG RT committee and the DBCG board.

Time Frame
Undecided.
Access Criteria
DBCG board.