ClinicalTrials.gg
Active, not recruitingNCT06549920DBCG IMNUpdated Aug 12, 2024

Danish Breast Cancer Group Internal Mammary Node Study

An interventional study of Internal mammary node irradiation in Breast Cancer, sponsored by Danish Breast Cancer Cooperative Group. Active, not recruiting. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 21 years 7 months after the study started (first participant enrolled Jan 2003, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
7,630
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Internal mammary node irradiation
  • Node-positive breast cancer
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 7,630 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Danish Breast Cancer Cooperative Group is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Prior , bilateral breast cancer, systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,630 participants (actual)

Study arms

  • Experimental
    Internal mammary node irradiation

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

    Radiation: Internal mammary node irradiation

  • No intervention
    No internal mammary node irradiation

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

Interventions

  • RadiationInternal mammary node irradiation

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

    Also known as: IMNI

06

What researchers measure

Primary outcomes

  1. Overall survival

    Censored at end of study or by emigration.

    Time frame: 15-years.

Secondary outcomes

  1. Breast cancer mortality

    Censored at end of study or by emigration.

    Time frame: 15-years.

  2. Distant recurrences

    Censored at end of study or by emigration. Death by any cause was regarded as competing event.

    Time frame: 15-years.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Data may be requested at the DBCG RT committee and the DBCG board.

Time frame: Undecided.

Access criteria: DBCG board.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06549920
Lead sponsor
Danish Breast Cancer Cooperative Group
Responsible party
Birgitte Offersen (Professor, Danish Breast Cancer Cooperative Group) — Principal investigator
First posted
Aug 12, 2024
Start date
Jan 1, 2003
Primary completion
Nov 17, 2023
Completion
Jan 1, 2034 (estimated)
Last update
Aug 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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