Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-28 @ 5:53 PM
Study NCT ID:
NCT02674204
Status:
TERMINATED
Last Update Posted:
2019-05-15
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STOP Heart Disease in Breast Cancer Survivors Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], '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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Marc.Goodman@cshs.org', 'phone': '310-423-6188', 'title': 'Marc Goodman, PhD', 'organization': 'Cedars-Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Accrual fell well below target. Two subjects were randomized to the study and one subject completed the study. Outcome measures were not analyzed due to insufficient accrual.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the 12-month intervention period and within 30 days of the last administration of the study drug.', 'description': 'Regular investigator assessment, regular laboratory testing, self-reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'abdominal cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'mood changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'baseline to 12 months post initiation of statin intervention', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in global circumferential strain (GCS) measured by Cardiac MRI (CMRI) was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Global Longitudinal Strain as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in global longitudinal strain as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Peak Left Ventricular Twist as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in peak left ventricular twist as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Peak Left Ventricular Torsion as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in peak left ventricular torsion as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Untwisting Rate as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in left ventricular untwisting rate as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Ejection Fraction as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in left ventricular ejection fraction as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular End Diastolic Volume as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in left ventricular end diastolic volume as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular End Systolic Volume as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in left ventricular end systolic volume as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Cardiac Output as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in cardiac output as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Mass as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in left ventricular mass as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Concentricity as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in left ventricular concentricity as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Native T1 as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in native T1 as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Post Contrast T1 as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in post contrast T1 as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Extracellular Volume as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in extracellular volume as measured by CMRI was not calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Native T2 as Measured by CMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'OG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'timeFrame': 'Baseline to 12 months of follow-up', 'reportingStatus': 'POSTED', 'populationDescription': 'As accrual fell well below target, change in native T2 as measured by CMRI was not calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'FG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day\n\nAtorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.'}, {'id': 'BG001', 'title': 'Control', 'description': 'One matching placebo daily\n\nPlacebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-29', 'size': 7222870, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-25T11:03', 'hasProtocol': True}, {'date': '2018-02-01', 'size': 1137943, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-03-25T11:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Closed due to low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-01', 'studyFirstSubmitDate': '2016-01-21', 'resultsFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-09', 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)', 'timeFrame': 'baseline to 12 months post initiation of statin intervention'}], 'secondaryOutcomes': [{'measure': 'Change in Global Longitudinal Strain as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Peak Left Ventricular Twist as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Peak Left Ventricular Torsion as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Left Ventricular Untwisting Rate as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Left Ventricular Ejection Fraction as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Left Ventricular End Diastolic Volume as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Left Ventricular End Systolic Volume as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Cardiac Output as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Left Ventricular Mass as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Left Ventricular Concentricity as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Native T1 as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Post Contrast T1 as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Extracellular Volume as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}, {'measure': 'Change in Native T2 as Measured by CMRI', 'timeFrame': 'Baseline to 12 months of follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Statin therapy', 'trastuzumab'], 'conditions': ['Breast Cancer', 'Heart Disease', 'Cardiotoxicity', 'Myocardial Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.', 'detailedDescription': 'This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with newly diagnosed stage 1-3 breast cancer\n* Histologically confirmed HER2, ER, and PR status\n* Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.\n* Age minimum 18 years\n* Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form\n* Willing and able to comply with trial protocol and follow-up\n* ECOG performance status 0-1 (Karnofsky ≥ 70%)\n\nExclusion Criteria:\n\n* Prior use of statin medication within the past year\n* Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol \\>190, or LDL \\<190 and ASCVD risk \\>7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is \\> 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy\n* History of adverse effects, intolerance, or allergic reactions attributed to statin medication\n* Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice\n* Current use of any other investigational agent\n* Pregnant or intention to get pregnant during the next 18 months. Pregnant women are excluded from this study because atorvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects, and MRI is contraindicated in pregnant women.\n* History of diabetes, severe lung disease, renal disease (creatinine \\> 1.8 mg/dL or CrCl ≤ 50 mL/min), or hepatic disease (AST and ALT \\> 3 times upper normal limits)\n* Abnormal baseline echocardiogram or cardiac MRI (detection of congenital heart disease; ischemic heart disease; moderate or severe valvular heart disease; cardiomyopathy; EF \\< 55%)\n* Previously known or diagnosed heart disease (e.g. congenital; valvular; coronary artery disease; history of myocardial infarction or acute coronary syndrome; cardiomyopathy, including infiltrative, hypertensive, hypertrophic, dilated, constrictive pericarditis, or other cardiomyopathy)\n* Left ventricular dysfunction (EF \\< 55%)\n* Prior non-cardiac illness with an estimated life expectancy \\< 4 years\n* Known active infection with HIV\n* Allergy or contraindication to MRI testing, including claustrophobia, metallic parts in body the prohibiting MRI, prior gadolinium contrast reaction, or uncontrolled moderate hypertension (sitting blood pressure \\>160/95 mm Hg with measurements recorded on at least 2 occasions).\n* Has metallic breast expanders in place at the time of screening\n* Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data'}, 'identificationModule': {'nctId': 'NCT02674204', 'acronym': 'STOP', 'briefTitle': 'STOP Heart Disease in Breast Cancer Survivors Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial', 'orgStudyIdInfo': {'id': 'IIT2015-12-Goodman-STOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Agent', 'description': 'One atorvastatin 20 mg oral capsule per day', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'One matching placebo daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor', 'Atorvastatin calcium'], 'description': 'Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.', 'armGroupLabels': ['Study Agent']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A substance that has no therapeutic effect, and will be used as a control in testing the study agent.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Marc Goodman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinal Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Breast Cancer Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Cancer Prevention & Control - Department, Cancer Institute', 'investigatorFullName': 'Marc Goodman', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}