Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04542135
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2020-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
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': 'D013467', 'term': 'Sulindac'}], 'ancestors': [{'id': 'D007192', 'term': 'Indenes'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in percent breast density by MRI between treatment arms', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in percent breast density by MRI between treatment arms', 'timeFrame': '6 months'}, {'measure': 'Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Density'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≤70 years\n2. Subject must be postmenopausal.\n3. Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable.\n4. Must have dense breasts\n5. Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition\n6. A negative fecal occult blood test\n7. Normal organ function\n8. Hormonal therapy with aromatase inhibitors is allowed\n\nExclusion Criteria:\n\n1. Daily aspirin or other daily anti inflammatory use.\n2. Known intolerance to anti inflammatory.\n3. Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months\n4. Gastrointestinal, bleeding or coagulation, cardiovascular disorders.\n5. Diabetes requiring insulin therapy.\n6. Current regular smoker.\n7. History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging.\n8. Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI.\n9. Uncontrolled hypertension.'}, 'identificationModule': {'nctId': 'NCT04542135', 'briefTitle': 'Sulindac and Breast Density in Women at Risk of Developing Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Double-blind, Randomized Phase II Clinical Trial of Sulindac for Reducing Breast Density in Postmenopausal Women at Risk of Developing Breast Cancer', 'orgStudyIdInfo': {'id': 'STOP-BC Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sulindac', 'description': 'sulindac 150 mg', 'interventionNames': ['Drug: Sulindac Pill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sulindac Pill', 'type': 'DRUG', 'description': 'Randomized participants will receive either 150 mg oral sulindac twice daily.', 'armGroupLabels': ['Sulindac']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo pills twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai - Cancer', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Alison S Stopeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}, {'name': 'Patricia A Thompson-Carino, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data to non study related researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alison Stopeck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alison Stopeck', 'investigatorAffiliation': 'Stony Brook University'}}}}