Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT06131632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058922', 'term': 'Inflammatory Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D015411', 'term': 'Mastectomy, Modified Radical'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015409', 'term': 'Mastectomy, Radical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local recurrence rate', 'timeFrame': '24 months', 'description': 'Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy'}], 'secondaryOutcomes': [{'measure': 'local recurrence-free survival', 'timeFrame': '24 months', 'description': 'Rate of disease free survival after breast conserving surgery vs radical mastectomy'}, {'measure': 'overall survival', 'timeFrame': '24 months', 'description': 'overall survival after breast conserving surgery vs radical mastectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammatory breast cancer', 'breast conserving surgery', 'radical mastectomy'], 'conditions': ['Inflammatory Breast Cancer']}, 'descriptionModule': {'briefSummary': "Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.\n\nCurrent treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.\n\nIn the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.\n\nThere are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inflammatory breast cancer\n* Clinical complete response after neoadjuvant chemiotherapy\n* Targeted tumor\n* Written informed consent\n\nExclusion Criteria:\n\n* Metastasis\n* Progression disease\n* Recurrent disease\n* Contraindications to adjuvant radiation therapy'}, 'identificationModule': {'nctId': 'NCT06131632', 'acronym': 'ConSIBreC', 'briefTitle': 'Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Consibrec Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast conserving surgery', 'interventionNames': ['Procedure: Breast conserving surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radical modified mastectomy', 'interventionNames': ['Procedure: Radical modified mastectomy']}], 'interventions': [{'name': 'Breast conserving surgery', 'type': 'PROCEDURE', 'description': 'Remove only a small part of the breast', 'armGroupLabels': ['Breast conserving surgery']}, {'name': 'Radical modified mastectomy', 'type': 'PROCEDURE', 'description': 'Remove all the breast parenchyma, nipple and skin', 'armGroupLabels': ['Radical modified mastectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'GIANLUCA FRANCESCHINI', 'role': 'CONTACT', 'email': 'gianluca.franceschini@policlinicogemelli.it', 'phone': '+390630155701'}, {'name': 'Lorenzo Scardina', 'role': 'CONTACT'}, {'name': 'GIANLUCA FRANCESCHINI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS,', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}