Breast CancerDBCG IMNNCT06549920
Danish Breast Cancer Group Internal Mammary Node Study
A study testing Internal mammary node irradiation in people with Breast Cancer, run by Danish Breast Cancer Cooperative Group.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Internal mammary node irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,630 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 1 Jan 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy.
Who cannot join
- Prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.
About this 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.
- Conditions
- Breast Cancer
- Being tested
- Internal mammary node irradiation
- Keywords
- Internal mammary node irradiation, Node-positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal mammary node irradiationRadiation
Also called IMNI
Irradiation of the internal mammary nodes in intercostal space 1-4.
| Study group | Role | What they receive |
|---|---|---|
| Internal mammary node irradiation | Experimental | Patients with right-sided breast cancer tumors were allocated to internal mammary node irradiation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Censored at end of study or by emigration.
Measured: 15-years.
Secondary outcomes (2)
Breast cancer mortality
Censored at end of study or by emigration.
Measured: 15-years.
Distant recurrences
Censored at end of study or by emigration. Death by any cause was regarded as competing event.
Measured: 15-years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Jan 2003
- Primary completion17 Nov 2023
- Study completion1 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Offersen, Danish Breast Cancer Cooperative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549920
- Sponsor's protocol ID
- DBCG IMN protocol
- Acronym
- DBCG IMN
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be requested at the DBCG RT committee and the DBCG board.
Publications
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.
PubMed 39810969
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Breast Cancer Group Internal Mammary Node Study
- ClinicalTrials.gov ID
- NCT06549920
- Acronym / sponsor ID
- DBCG IMN / DBCG IMN protocol
- Conditions
- Breast Cancer
- Keywords
- Internal mammary node irradiation, Node-positive breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,630 participants (actual)
- Lead sponsor
- Danish Breast Cancer Cooperative GroupUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 1 Jan 2034 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal mammary node irradiation | Experimental | Radiation: Internal mammary node irradiationPatients with right-sided breast cancer tumors were allocated to 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy.
Key exclusion criteria (1 listed)
- Prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal mammary node irradiationAlso: IMNIIrradiation of the internal mammary nodes in intercostal space 1-4. | Radiation | Internal mammary node irradiation |
Primary outcome
Overall survival
Time frame: 15-years.
Censored at end of study or by emigration.
2 secondary outcomes
Breast cancer mortality
Time frame: 15-years.
Distant recurrences
Time frame: 15-years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 39810969Nielsen 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.
- Individual participant dataSharing planned: Yes. Data may be requested at the DBCG RT committee and the DBCG board.
Related trials for Breast Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
RecruitingPhase 2
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Internal mammary node irradiation in people with Breast Cancer, run by Danish Breast Cancer Cooperative Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 15-years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06549920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.