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Active, not recruiting

NCT Number: NCT06549920

Danish Breast Cancer Group Internal Mammary Node Study

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal mammary node irradiation

Radiation

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

Other names: IMNI

Primary outcomes

  1. Overall survival

    Time frame: 15-years.

    Censored at end of study or by emigration.

Secondary outcomes

  1. Breast cancer mortality

    Time frame: 15-years.

    Censored at end of study or by emigration.

  2. Distant recurrences

    Time frame: 15-years.

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

Sponsors and collaborators

Lead sponsor

Danish Breast Cancer Cooperative Group

Other

Registry information

Acronym: DBCG IMN

Important dates

Study start
2003
Primary completion
2023
Study completion
2034
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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