Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-26 @ 11:32 PM
Study NCT ID:
NCT05893966
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2032-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral breast tumor recurrence', 'timeFrame': '7 years from the start of the postoperative radiation therapy', 'description': 'The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '7 years from the start of the postoperative radiation therapy', 'description': 'The event for disease-free survival (DFS) was defined as any local, regional, or distant recurrence or breast cancer-related death.'}, {'measure': 'Locoregional recurrence', 'timeFrame': '7 years from the start of the postoperative radiation therapy', 'description': 'The event for locoregional recurrence was defined as recurrence in irradiated breast / chest wall or regional lymph node area.'}, {'measure': 'Overall survival', 'timeFrame': '7 years from the start of the postoperative radiation therapy', 'description': 'The event for overall survival (OS) was defined as death of any cause.'}, {'measure': 'Adverse events', 'timeFrame': '7 years from the start of the postoperative radiation therapy', 'description': 'Adverse events were evaluated and graded according to CTCAE version 5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.\n\nThe main questions it aims to answer are:\n\n* 7-year ipsilateral breast tumor recurrence\n* 7-year disease-free survival\n* 7-year locoregional recurrence\n* 7-year overall survival\n* Adverse events of radiation therapy\n\nParticipants will be assessed by multi-dimensional methods after radiation therapy:\n\n* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination\n* Assessment for the adverse events according to CTCAE version 5.0'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any HER2+ invasive breast cancer patient with eligible performance except previous history of radiation therapy to ipsilateral breast', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with age minimum 19\n* Pathological confirmation of HER2+ invasive breast cancer\n* Eastern Cooperative Oncology Group performance status 0-2\n* Informed consent of the participant\n\nExclusion Criteria:\n\n* Pathological confirmation of ductal carcinoma in situ of the breast\n* Previous history of radiation therapy to ipsilateral breast'}, 'identificationModule': {'nctId': 'NCT05893966', 'acronym': 'BOOST-HER2', 'briefTitle': 'Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer', 'orgStudyIdInfo': {'id': '2022-11-018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Whole breast irradiation +/- tumor bed boost', 'type': 'RADIATION', 'description': 'Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Haeyoung Kim, MD, PhD', 'role': 'CONTACT', 'email': 'haeyoung0131.kim@samsung.com', 'phone': '82-2-3410-2612'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Haeyoung Kim, MD, PhD', 'role': 'CONTACT', 'email': 'haeyoung0131.kim@samsung.com', 'phone': '82-2-3410-2612'}], 'overallOfficials': [{'name': 'Haeyoung Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Haeyoung Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}