Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06549920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Danish Breast Cancer Group Internal Mammary Node Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7630}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2034-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '15-years.', 'description': 'Censored at end of study or by emigration.'}], 'secondaryOutcomes': [{'measure': 'Breast cancer mortality', 'timeFrame': '15-years.', 'description': 'Censored at end of study or by emigration.'}, {'measure': 'Distant recurrences', 'timeFrame': '15-years.', 'description': 'Censored at end of study or by emigration. Death by any cause was regarded as competing event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internal mammary node irradiation', 'Node-positive breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39810969', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy.\n\nExclusion Criteria:\n\n* Prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.'}, 'identificationModule': {'nctId': 'NCT06549920', 'acronym': 'DBCG IMN', 'briefTitle': 'Danish Breast Cancer Group Internal Mammary Node Study', 'organization': {'class': 'OTHER', 'fullName': 'Danish Breast Cancer Cooperative Group'}, 'officialTitle': 'Danish Breast Cancer Group Internal Mammary Node Study', 'orgStudyIdInfo': {'id': 'DBCG IMN protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internal mammary node irradiation', 'description': 'Patients with right-sided breast cancer tumors were allocated to internal mammary node irradiation.', 'interventionNames': ['Radiation: Internal mammary node irradiation']}, {'type': 'NO_INTERVENTION', 'label': 'No internal mammary node irradiation', 'description': 'Patients with left-sided breast cancer tumors were allocated to no internal mammary node irradiation.'}], 'interventions': [{'name': 'Internal mammary node irradiation', 'type': 'RADIATION', 'otherNames': ['IMNI'], 'description': 'Irradiation of the internal mammary nodes in intercostal space 1-4.', 'armGroupLabels': ['Internal mammary node irradiation']}]}, 'ipdSharingStatementModule': {'timeFrame': 'Undecided.', 'ipdSharing': 'YES', 'description': 'Data may be requested at the DBCG RT committee and the DBCG board.', 'accessCriteria': 'DBCG board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Breast Cancer Cooperative Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Birgitte Offersen', 'investigatorAffiliation': 'Danish Breast Cancer Cooperative Group'}}}}