Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 1:14 AM
Study NCT ID:
NCT06092892
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2023-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}], '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': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}, {'id': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label, single arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-16', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional recurrence rate', 'timeFrame': '5 Years', 'description': 'Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Local recurrence rate', 'timeFrame': '5 Years', 'description': 'Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': '5 Years', 'description': 'Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer.'}, {'measure': 'Breast cancer specific survival (BCSS) rate', 'timeFrame': '5 Years', 'description': 'Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period'}, {'measure': 'Overall survival (OS)', 'timeFrame': '5 Years', 'description': 'Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T1-2N0 ER+ invasive', 'biopsy', 'upfront lumpectomy'], 'conditions': ['Breast Cancer', 'Axillary Nodal Disease', 'Female Breast Cancer', 'Axilla; Breast', 'Mastectomy; Lymphedema', 'Tumor, Breast']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age ≥ 45\n* Clinical T1-2N0 ER+ invasive breast cancer\n* US detected biopsy proven axillary nodal disease\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Palpable nodes on physical exam\n* Her2+ or ER- invasive breast cancer\n* Extranodal extension \\> 3 mm on nodal biopsy\n* More than 2 suspicious nodes on preoperative imaging'}, 'identificationModule': {'nctId': 'NCT06092892', 'briefTitle': 'IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases', 'orgStudyIdInfo': {'id': 'IIT2023-09-Chung-UpfrontTAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB', 'Radiation: Adjuvant Radiation Therapy']}], 'interventions': [{'name': 'Breast Surgery (BCS or mastectomy) with TAD/SNB', 'type': 'PROCEDURE', 'description': 'Breast surgery (BCS or mastectomy) with TAD/SNB \\& Adjuvant Radiation therapy', 'armGroupLabels': ['Single Arm']}, {'name': 'Adjuvant Radiation Therapy', 'type': 'RADIATION', 'description': 'Breast surgery (BCS or mastectomy) with TAD/SNB \\& Adjuvant Radiation therapy', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Oppenheim', 'role': 'CONTACT', 'email': 'Amy.Oppenheim@cshs.org', 'phone': '310-423-3713'}, {'name': 'Scott Karlan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Armando Giuliano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catherine Dang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Farin Amersi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alice Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marissa Boyle, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kjirsten Carlson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephen Shiao, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie Jang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michele Burnison, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amin Mirhadi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '424-314-0177'}, {'name': 'Jeannie Shen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amy Polverini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alicia Terando, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CS Cancer at Huntington Cancer Center', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanessa Vasco', 'role': 'CONTACT', 'email': 'Vanessa.Vasco@cshs.org'}, {'name': 'Lauren DeStefano, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CS Cancer at Valley Oncology Medical Group', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}], 'centralContacts': [{'name': 'Clinical Trial Navigator', 'role': 'CONTACT', 'email': 'cancer.trial.info@cshs.org', 'phone': '3104232133'}], 'overallOfficials': [{'name': 'Alice Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alice Chung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Alice Chung', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}