Danish Breast Cancer Group Internal Mammary Node Study (DBCG IMN)

August 8, 2024 updated by: Birgitte Offersen, Danish Breast Cancer Cooperative Group
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7630

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internal mammary node irradiation
Patients with right-sided breast cancer tumors were allocated to internal mammary node irradiation.
Radiation: Internal mammary node irradiation
Irradiation of the internal mammary nodes in intercostal space 1-4.
Other Names:
  • IMNI
No Intervention: No internal mammary node irradiation
Patients with left-sided breast cancer tumors were allocated to no internal mammary node irradiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 15-years.
Censored at end of study or by emigration.
15-years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast cancer mortality
Time Frame: 15-years.
Censored at end of study or by emigration.
15-years.
Distant recurrences
Time Frame: 15-years.
Censored at end of study or by emigration. Death by any cause was regarded as competing event.
15-years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Breast Cancer Cooperative Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2003

Primary Completion (Actual)

November 17, 2023

Study Completion (Estimated)

January 1, 2034

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBCG IMN protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Undecided.

IPD Sharing Access Criteria

DBCG board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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