Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00899418
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studying Tumor Tissue Samples to Learn More About DNA Changes and Response in Patients With Breast Cancer Treated With Bevacizumab on Clinical Trial ECOG-2100
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': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression in patients with a known polymorphism vs those with wild-type vascular endothelial growth factor (VEGF) gene'}], 'secondaryOutcomes': [{'measure': 'Time to progression in patients with a known polymorphism vs those with wild-type VEGF receptor-2 (KDR) gene'}, {'measure': 'Difference in response rate, survival, and toxicity in patients with a known polymorphism vs wild-type VEGF and KDR'}]}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.\n\nPURPOSE: This laboratory study is examining tumor tissue samples from patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100 to learn more about DNA changes and response in these patients.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Assess the effect of known variant polymorphisms (with functionally important associations) of the vascular endothelial growth factor (VEGF) gene on outcome (time to progression) in patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100.\n\nSecondary\n\n* Assess the effect of known variant polymorphisms (with functionally important associations) of the VEGF receptor-2 (KDR) gene on outcome (time to progression) in these patients.\n* Assess the effect of known variant polymorphisms of these genes on efficacy (objective response rate and survival) in these patients.\n* Assess the effect of known variant polymorphisms of these genes on toxicity outcome in these patients.\n* Assess the effect of VEGF polymorphisms on VEGF expression by immunohistochemical staining (a known prognostic marker).\n* Assess the effect of KDR polymorphisms on KDR expression by immunohistochemical staining.\n\nOUTLINE: This is a multicenter study.\n\nTissue and genomic DNA samples from paraffin-embedded primary tumor are examined using standard polymerase chain reaction (PCR) restriction fragment-length polymorphisms, immunohistochemistry, allele-specific PCR, and/or Taqman-based assays. Vascular endothelial growth factor (VEGF) and VEGF receptor-2 (KDR) expression and polymorphisms are assessed.\n\nPROJECTED ACCRUAL: A total of 500 specimens will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the breast\n* Enrolled on clinical trial ECOG-2100 and received treatment with bevacizumab\n* Paraffin-embedded tumor samples available\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00899418', 'briefTitle': 'Studying Tumor Tissue Samples to Learn More About DNA Changes and Response in Patients With Breast Cancer Treated With Bevacizumab on Clinical Trial ECOG-2100', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Differential Response of Breast Cancer Patients on E2100 Treated With Bevacizumab as a Function of Genetic Polymorphisms of VEGF and KDR', 'orgStudyIdInfo': {'id': 'CDR0000472065'}, 'secondaryIdInfos': [{'id': 'U10CA021115', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021115', 'type': 'NIH'}, {'id': 'ECOG-E2100T1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'polymorphism analysis', 'type': 'GENETIC'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bryan P. Schneider, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Indiana University Melvin and Bren Simon Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}