Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-26 @ 3:05 PM
Study NCT ID:
NCT00285857
Status:
TERMINATED
Last Update Posted:
2017-03-09
First Post:
2006-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D008148', 'term': 'Lovastatin'}, {'id': 'C451780', 'term': 'lovastatin-niacin combination'}, {'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmf@stanford.edu', 'phone': '(650) 498-6689', 'title': 'James M. Ford', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lovastatin', 'description': 'Lovastatin: 80 mg; 40 mg orally twice per day', 'otherNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Non-proliferative Breast Disease (NPBD)', 'description': 'Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of non-proliferative breast disease'}, {'id': 'OG001', 'title': 'Baseline Proliferative Breast Disease Without Atypia (PBD-A)', 'description': 'Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease without atypia'}, {'id': 'OG002', 'title': 'Baseline Proliferative Breast Disease With Atypia (PBD+A)', 'description': 'Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease with atypia'}, {'id': 'OG003', 'title': 'Baseline Carcinoma in Situ or Invasive Cancer (CIS/IC)', 'description': 'Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of carcinoma in situ or invasive cancer'}, {'id': 'OG004', 'title': 'Baseline Biopsy Acellular', 'description': 'Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) generated a sample that was acellular'}], 'classes': [{'title': 'Post-treatment NPBD', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Post-treatment PBD-A', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Post-treatment PBD+A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Post-treatment CIS/IC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Post-treatment biopsy acellular', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day.\n\nCytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows:\n\n06-10 Non-proliferative breast disease (NPBD)\n\n11-14 Proliferative breast disease without atypia (PBD-A)\n\n15-18 Proliferative breast disease with atypia (PBD+A)\n\n19-24 Carcinoma in situ and invasive cancer (CIS/IC)\n\nIf no cells could be obtained after multiple RPFNA attempts, the classification was acellular.\n\nChange from NPBD to PBD-A was considered Unfavorable.\n\nChange from NPBD to Acellular was considered Equivocal.\n\nChange from PBD-A to NPBD was considered Favorable.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants either at least one of the following:\n\n* Deleterious germline mutation in BRCA1, BRCA2, CDH1, or TP53\n* Lifetime breast cancer risk of breast cancer of 20 % as estimated by the Claus model\n* Personal history of estrogen receptor andprogesterone receptor-negative breast cancer.'}, {'type': 'SECONDARY', 'title': 'Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovastatin 80 mg/Day', 'description': 'Lovastatin 80 mg/day given as 40 mg orally twice per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '1.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment.\n\nCategory 0 Need additional imaging evaluation\n\n1. Negative\n2. Benign\n3. Probably benign\n4. Suspicious abnormality\n5. Highly suggestive of malignancy\n6. Known biopsy-proven malignancy', 'unitOfMeasure': 'BI-RADS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome reported as the change in mean mammographic density with standard deviation (SD) of the post-treatment measurements.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovastatin 80 mg/Day', 'description': 'Lovastatin 80 mg/day given as 40 mg orally twice per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-8', 'spread': '45.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lovastatin 80 mg/Day', 'description': 'Lovastatin 80 mg/day given as 40 mg orally twice per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-6', 'spread': '32.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in mean of LDL level, with standard deviation of the values at'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lovastatin 80 mg/Day', 'description': 'Lovastatin 80 mg/day given as 40 mg orally twice per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Inadequate initial breast cytology', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lovastatin', 'description': 'Lovastatin: 80 mg; 40 mg orally twice per day'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2006-01-31', 'resultsFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-19', 'studyFirstPostDateStruct': {'date': '2006-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day', 'timeFrame': '6 months', 'description': 'Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day.\n\nCytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows:\n\n06-10 Non-proliferative breast disease (NPBD)\n\n11-14 Proliferative breast disease without atypia (PBD-A)\n\n15-18 Proliferative breast disease with atypia (PBD+A)\n\n19-24 Carcinoma in situ and invasive cancer (CIS/IC)\n\nIf no cells could be obtained after multiple RPFNA attempts, the classification was acellular.\n\nChange from NPBD to PBD-A was considered Unfavorable.\n\nChange from NPBD to Acellular was considered Equivocal.\n\nChange from PBD-A to NPBD was considered Favorable.'}], 'secondaryOutcomes': [{'measure': 'Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day', 'timeFrame': '6 months', 'description': 'Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment.\n\nCategory 0 Need additional imaging evaluation\n\n1. Negative\n2. Benign\n3. Probably benign\n4. Suspicious abnormality\n5. Highly suggestive of malignancy\n6. Known biopsy-proven malignancy'}, {'measure': 'Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day', 'timeFrame': '6 months'}, {'measure': 'Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['duct cytology'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24166281', 'type': 'RESULT', 'citation': 'Vinayak S, Schwartz EJ, Jensen K, Lipson J, Alli E, McPherson L, Fernandez AM, Sharma VB, Staton A, Mills MA, Schackmann EA, Telli ML, Kardashian A, Ford JM, Kurian AW. A clinical trial of lovastatin for modification of biomarkers associated with breast cancer risk. Breast Cancer Res Treat. 2013 Nov;142(2):389-98. doi: 10.1007/s10549-013-2739-z. Epub 2013 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk.', 'detailedDescription': 'The study evaluates if a 6-month course of oral lovastatin at 80 mg/day (as 40 mg twice-a-day) would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk. Breast duct cytology was assessed as hyperplasia or hyperplasia with atypia, as measured by random periareolar fine needle aspiration (rpFNA), of breast duct cells.\n\nA stratified analysis of this objective will be performed according to BRCA mutation status (absence or presence of an inherited deleterious BRCA1 or BRCA2 mutation).\n\nAdditional objectives of the study are to:\n\n* Assess change in mammographic density, which is known to associate with breast cancer risk, before and after treatment with lovastatin\n* Asess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.\n* Assess change in other breast cancer risk-associated biomarkers in rpFNA specimens, including:\n\n * Ki-67 (a marker of cell proliferation)\n * Estrogen receptor (ER)\n * Progesterone receptor (PR)\n * HER/2-neu over-expression\n * Susceptibility to DNA damage'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Female\n* Increased inherited risk of breast cancer, as defined by:\n\n * Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation\n * Family history conveying at least a 2-fold increase in breast cancer risk\n* ECOG performance status 0\n* Normal organ and marrow function, including complete blood count and comprehensive metabolic panel within normal institutional limits\n* Subject agreement to limit alcoholic beverage consumption to three alcoholic drinks per week.\n\nEXCLUSION CRITERIA\n\n* Prior history of invasive breast cancer less than 2 years previously (EXCEPTION: stage III or lower breast cancer \\> 2 years ago)\n* Current or history of other cancers (EXCEPTION: non-melanoma skin cancer, or stage III or cancer without evidence of recurrence for 5 years\n* Initial mammogram, breast MRI, or clinical breast examination prompts recommendation for biopsy by study investigators.\n* Evidence of malignant cytology on initial rpFNA.\n* Use of other investigational agents.\n* Use of tamoxifen or selective estrogen response modifiers (SERMS), including raloxifene, within the last 2 years.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.\n* Currently receiving lovastatin and cyclosporine, gemfibrozil, erythromycin, fibrates or niacin, (unless discontinued for study participation)\n* No evidence of active liver disease, nor elevation of serum transaminases (prior history of liver disease, if not currently active, is not an exclusion)\n* No evidence of myopathy or myositis, including symptoms of generalized muscle aches or weakness, muscle tenderness, or elevation in creatine phosphokinase.\n* Lactating (breastfeeding)'}, 'identificationModule': {'nctId': 'NCT00285857', 'briefTitle': 'Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Phase 2 Trial of Lovastatin for Modification of Abnormal Breast Duct Cytology and Risk-Associated Biomarkers in Women at High Inherited Risk of Breast Cancer', 'orgStudyIdInfo': {'id': 'IRB-13732'}, 'secondaryIdInfos': [{'id': 'BRSNSTU0010', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': '95505', 'type': 'OTHER', 'domain': 'Stanford University Alternate IRB Approval Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lovastatin 80 mg/day', 'description': 'Lovastatin 80 mg/day as 40 mg orally twice daily, for 6 months.', 'interventionNames': ['Drug: Lovastatin']}], 'interventions': [{'name': 'Lovastatin', 'type': 'DRUG', 'otherNames': ['Mevacor', 'Advicor (as a combination with niacin)', 'Altocor', 'Altoprev', 'Statosan (Atos Pharma)'], 'description': 'Lovastatin 80 mg/day as 40 mg orally twice daily.\n\nLovastatin is approved by FDA as a cholesterol-lowering agent.', 'armGroupLabels': ['Lovastatin 80 mg/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'James Ford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'James Ford', 'investigatorAffiliation': 'Stanford University'}}}}