Danish Breast Cancer Group Internal Mammary Node Study

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06549920
• Lead Sponsor: Danish Breast Cancer Cooperative Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01-01
• Primary Completion: 2023-11-17
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Study Completion: 2034-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7630

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	15-years.	Censored at end of study or by emigration.

Secondary Outcome Measures

Name	Time	Method
Breast cancer mortality	15-years.	Censored at end of study or by emigration.
Distant recurrences	15-years.	Censored at end of study or by emigration. Death by any cause was regarded as competing event.