Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01302002
Status:
WITHDRAWN
Last Update Posted:
2016-02-23
First Post:
2011-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Metformin in Early Breast Cancer Patients Pre-Surgery
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': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014015', 'term': 'Tissue Banks'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D018070', 'term': 'Biological Specimen Banks'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2011-02-14', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the in situ effects of metformin in women with operable stage I or II breast cancer', 'timeFrame': '60 days after the surgery', 'description': 'To determine the in situ effects of metformin on\n\n* proliferation (Ki67) and apoptosis (TUNEL), fosforilate AKT\n* CD1a CD83, CD68, F40/80, arginase iNOS and T cells -CD4(+),CD45RA(+), CD 45RO, CD4, CD8 and FOXP3(+).'}], 'secondaryOutcomes': [{'measure': 'To analyse gastrointestinal toxicity', 'timeFrame': 'One week , 2 weeks and 20 days after Metformim beginning', 'description': '* To analyse gastrointestinal toxicity grade (examples: nausea, stomach pain, vomiting)\n* Number of Participants with Adverse Events'}, {'measure': 'To analyse the blood tests one day before the biopsy and one day before the surgery', 'timeFrame': '5 days after blood collection', 'description': '-To collect and analyze pre- and post-treatment peripheral blood specimens for serum glucose, glycosylated haemoglobin and insulin levels, as well as circulating IGF-1 and estradiol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Metformin', 'Pre-Surgery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.', 'detailedDescription': 'Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue.\n\nThe study will collect and analyze pre- and post-treatment blood specimens for:\n\n* Serum glucose\n* Insulin levels\n* Estradiol\n* HOMA test\n* Glycosylated haemoglobin'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive breast cancer T1 or T2, Nx\n* Knowledge of the investigational nature of the study and ability to provide consent for study participation\n\nExclusion Criteria:\n\n* Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution\n* Recent use of corticosteroids\n* AST \\> 1.5 times upper limit of normal for the institution\n* Pregnancy\n* Serious clinical illness\n* Prior or concurrent systemic neoadjuvant Breast Cancer therapy.'}, 'identificationModule': {'nctId': 'NCT01302002', 'briefTitle': 'The Use of Metformin in Early Breast Cancer Patients Pre-Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Nacional de Cancer, Brazil'}, 'officialTitle': 'The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect', 'orgStudyIdInfo': {'id': 'INCA113/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin Pre-Surgery', 'description': 'Patients will take metformin twice a day for three weeks prior surgery', 'interventionNames': ['Drug: Metformin Pre-Surgery']}], 'interventions': [{'name': 'Metformin Pre-Surgery', 'type': 'DRUG', 'otherNames': ['Laboratory biomarker analysis', 'Blood and tissue collection'], 'description': '500 mg tablet, taken twice a day for 3 weeks', 'armGroupLabels': ['Metformin Pre-Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20560-120', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital do Cancer III', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Ana Elisa Lohmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cancer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cancer, Brazil', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Oncologist', 'investigatorFullName': 'Ana Elisa Lohmann', 'investigatorAffiliation': 'Instituto Nacional de Cancer, Brazil'}}}}