Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-24 @ 11:44 PM
Study NCT ID:
NCT05371860
Status:
WITHDRAWN
Last Update Posted:
2023-09-22
First Post:
2022-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000095384', 'term': 'Pathologic Complete Response'}], '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'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI voluntarily closed the study. Will be reopened as a national cooperative group trial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial', 'timeFrame': 'At time of consent. Assessed up to 3 years', 'description': 'Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2', 'partial mastectomy', 'lumpectomy', 'sentinel node biopsy', 'axillary node dissection', 'pathologic complete response', 'breast cancer', 'HER2-positive'], 'conditions': ['Breast Cancer', 'HER2-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age ≥ 40 years\n* Patients must have a tissue diagnosis of HER2+ breast cancer\n* Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy\n* Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist\n* Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection.\n* Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis)\n\nExclusion Criteria:\n\n* Breastfeeding\n* Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast\n* Prior adjuvant radiation therapy\n* Patients with diagnosis of inflammatory breast cancer\n* Patients with known BRCA mutation or other known breast cancer related deleterious mutations'}, 'identificationModule': {'nctId': 'NCT05371860', 'briefTitle': 'Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic', 'orgStudyIdInfo': {'id': 'IIT2021-10-Giuliano-OmitRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omit breast radiation', 'interventionNames': ['Other: Omit breast radiation']}], 'interventions': [{'name': 'Omit breast radiation', 'type': 'OTHER', 'description': 'Omit breast radiation for 3 years after surgery', 'armGroupLabels': ['Omit breast radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Armando Giuliano, MD, FACS, FRCSEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armando Giuliano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, Surgical Oncology', 'investigatorFullName': 'Armando Giuliano', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}