Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT05126667
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2021-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}, {'id': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9710}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of ipsilateral breast tumor recurrence', 'timeFrame': '10 years', 'description': 'Incidence of ipsilateral breast tumor recurrence in breast conserving surgery group compared to mastectomy group'}, {'measure': 'Cumulative incidence of axillary lymph node recurrence', 'timeFrame': '10 years', 'description': 'cumulative incidence of axillary lymph node recurrence in breast conserving surgery group compared to mastectomy group'}, {'measure': 'Cumulative incidence of contralateral breast cancer', 'timeFrame': '10 years', 'description': 'Cumulative incidence of contralateral breast cancer in breast conserving surgery group compared to mastectomy group'}, {'measure': 'Rate of distant metastasis', 'timeFrame': '10 years', 'description': 'Incidence of distant metastasis in breast conserving surgery group compared to mastectomy group'}, {'measure': 'Cumulative incidence of breast cancer specific survival', 'timeFrame': '10 years', 'description': 'Cumulative incidence of breast cancer specific survival in breast conserving surgery group compared to mastectomy group'}, {'measure': 'Rate of overall survival', 'timeFrame': '10 years', 'description': 'Incidence of survival in breast conserving surgery group compared to mastectomy group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a retrospective propensity score-matched analysis of a large institutional cohort of patients in order to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery or mastectomy for breast cancer.', 'detailedDescription': 'The aim of the study is to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery + whole breast irradiation or mastectomy for breast cancer.\n\nRecent observations regarding long-term outcomes among patients with early-stage breast cancer who underwent breast-conserving surgery plus whole-breast irradiation or mastectomy are from a small number of registry-based studies.\n\nTherefore, these findings may overestimate differences in survival between the two groups, compared with randomized controlled trials conducted in the 1980s.\n\nThis study performed a propensity score-matched analysis in a cohort of 9710 patients aged \\<70 years who underwent breast conserving surgery + whole breast irradiation or mastectomy without external radiotherapy for a first primary breast cancer (pT1-2, N0-3a) at the European Institute of Oncology between 2000 and 2008.\n\nPatients were matched by propensity score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospectively analysis of patients who received treatment for invasive breast cancer at the European Institute of Oncology between January 1, 2000, and December 31, 2008.\n\nThe original cohort comprised 9710 eligible patients with breast cancer, of whom 2289 (23.6%) underwent breast conserving surgery + whole breast irradiation and 7421 (76.4%) underwent mastectomy alone.\n\nAfter propensity score matching, 1970 of the 2289 patients who underwent mastectomy (86.1%) were successfully matched to 1970 patients who underwent breast conserving surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First primary breast cancer\n* pT1-2\n* pN0-3a\n* Surgery performed at European Institute of Oncology between 2000 and 2008\n\nExclusion Criteria:\n\n* pT\\>=3\n* Neoadjuvant treatment\n* Presence of metastatic breast disease at the time of admission or within 3 months'}, 'identificationModule': {'nctId': 'NCT05126667', 'briefTitle': 'Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'A Propensity Score-Matched Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy in Breast Cancer', 'orgStudyIdInfo': {'id': 'UID 2762'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast-conserving surgery', 'description': 'Patients who underwent breast-conserving surgery plus whole-breast irradiation', 'interventionNames': ['Procedure: Breast-conserving surgery']}, {'label': 'Mastectomy', 'description': 'Patients who underwent mastectomy', 'interventionNames': ['Procedure: Mastectomy']}], 'interventions': [{'name': 'Breast-conserving surgery', 'type': 'PROCEDURE', 'description': 'Breast conserving surgery plus whole breast irradiation', 'armGroupLabels': ['Breast-conserving surgery']}, {'name': 'Mastectomy', 'type': 'PROCEDURE', 'description': 'Breast mastectomy', 'armGroupLabels': ['Mastectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Francesca Magnoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}