Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00909506
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2009-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2009-05-27', 'studyFirstSubmitQcDate': '2009-05-27', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.\n\nIn this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS \\< 126\n* From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy\n* No drug use except Tamoxifen\n* Normal OTPT \\& Serum creatinine (\\<=ULN)\n* ECOG performance status 0-2 or Karnofsky PS 60-100%\n* Life expectancy \\> 12\n* Absolute neutrophil count ≥ 1.5 x 10\\^9/L\n* Platelets ≥ 100 x 10\\^9/L\n* Pregnancy(-) \\& without plan for pregnancy\n* Sign a written informed consent form\n\nExclusion Criteria:\n\n* Type I or II DM or concurrent use of DM control agents\n* Prior use of Metformin\n* Hypoglycemia (FBS\\< 70 with clinical symptom)\n* Concurrent investigational or commercial agents\n* Other diet or drug intervention for weight loss\n* Concurrent use of steroid\n* Abnormal liver and/or renal function\n* Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris\n* Ongoing or active infection\n* lactic acidosis\n* Pregnancy or ongoing breast feeding\n* Anorexia, bulimia, nausea due to other disease for longer than 1 month\n* Allergies or allergic reactions attributed to oral medications\n* Inability to swallow or digest oral medications\n* Physical or psychiatric illness that would limit compliance with study protocol\n* Participants in other clinical trial'}, 'identificationModule': {'nctId': 'NCT00909506', 'briefTitle': 'Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'adjuvant metformin for BC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin 500 mg/d', 'description': 'Metformin 500 mg/d', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin 1000 mg/d', 'description': 'Metformin 1000 mg/d', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Control: Receive placebo pill once every evening on 1\\~2 weeks.\n\nReceive placebo pill in every morning and evening on 3\\~24 weeks (twice a day).', 'armGroupLabels': ['Placebo']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 500 mg/d: Receive oral metformin 500 mg dose once daily on 1\\~2 weeks.\n\nReceive placebo pill in every morning and oral metformin 500 mg in every evening on 3\\~24 weeks.', 'armGroupLabels': ['Metformin 500 mg/d']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 1000 mg/d : Receive oral metformin 500 mg dose once daily on 1\\~2 weeks. (Dose-escalate)\n\nReceive oral metformin 500 mg in every morning and evening on 3\\~24 weeks (metformin 500 mg \\* twice a day = 1000 mg per day).', 'armGroupLabels': ['Metformin 1000 mg/d']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wonshik Han, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}