Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00080860
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2004-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Finding Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D021701', 'term': 'Sentinel Lymph Node Biopsy'}, {'id': 'D013671', 'term': 'Technetium Tc 99m Sulfur Colloid'}], 'ancestors': [{'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017556', 'term': 'Technetium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'DIAGNOSTIC'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2004-04-07', 'studyFirstSubmitQcDate': '2004-04-07', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Sentinel lymph node biopsy and gene expression profiling of the primary breast tumor may help determine if tumor cells have spread to the axillary lymph nodes and help doctors plan more effective surgery for breast cancer.\n\nPURPOSE: This clinical trial is studying how well sentinel lymph node biopsy and primary tumor gene expression profiling work in finding lymph node metastases in women who have received neoadjuvant therapy for stage II, stage III, or stage IV breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node status after neoadjuvant therapy in women with stage II, III, or IV breast cancer.\n* Correlate gene expression profiling of the primary breast cancer with axillary and sentinel lymph node status in these patients.\n\nOUTLINE: This is a pilot study.\n\nAfter neoadjuvant chemotherapy, patients undergo sentinel lymph node (SLN) mapping comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify the SLN. Within 1-2 hours after injection, patients undergo SLN biopsy followed immediately by definitive local surgery comprising modified radical mastectomy or breast segmentectomy with axillary lymph node dissection. SLN and axillary lymph nodes are examined by hematoxylin and eosin (H \\& E) staining for the presence or absence of metastases. If the lymph nodes are negative for tumor by H \\& E, the lymph nodes are further analyzed by immunohistochemistry. The primary tumor is analyzed by microarray analysis for gene expression profile determinations.\n\nPatients are followed at 2-3 weeks after surgery.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2-3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed carcinoma of the breast\n\n * Stage II, III, or IV infiltrating disease\n * Unilateral or bilateral AND unifocal or multifocal disease\n* Received at least 1 course of prior preoperative therapy (chemotherapy, hormonal therapy, and/or biologic therapy) AND had any of the following responses:\n\n * Clinical complete response, partial response, no change, or disease progression\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Hemoglobin \\> 7.0 g/dL\n* Platelet count \\> 50,000/mm\\^3\n* WBC \\> 2,000/mm\\^3\n\nHepatic\n\n* PT and PTT \\< 1.5 times normal\n\nRenal\n\n* Not specified\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* See Disease Characteristics\n\nRadiotherapy\n\n* No prior definitive breast radiotherapy to the target breast\n\nSurgery\n\n* No prior axillary surgery on the side of the sentinel lymph node\n\nOther\n\n* More than 3 days since prior radionuclide scan (e.g., bone scan, positron-emission tomography scan, or MUGA scan)'}, 'identificationModule': {'nctId': 'NCT00080860', 'briefTitle': 'Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Finding Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer', 'nctIdAliases': ['NCT00076895'], 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer', 'orgStudyIdInfo': {'id': '040114'}, 'secondaryIdInfos': [{'id': '04-C-0114'}, {'id': 'CDR0000356050'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'microarray analysis', 'type': 'GENETIC'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'lymphangiography', 'type': 'PROCEDURE'}, {'name': 'radionuclide imaging', 'type': 'PROCEDURE'}, {'name': 'sentinel lymph node biopsy', 'type': 'PROCEDURE'}, {'name': 'technetium Tc 99m sulfur colloid', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'David N. Danforth, MD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Surgery Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}