Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 8:01 AM
Study NCT ID:
NCT00416403
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2006-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077340', 'term': 'Fluvastatin'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-12', 'studyFirstSubmitDate': '2006-12-27', 'studyFirstSubmitQcDate': '2006-12-27', 'lastUpdatePostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in proliferation after statin exposure, as measured by Ki-67 level', 'timeFrame': 'up to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Blood and serum markers, including C-reactive protein, cleaved caspase 3, HER2, CD68, macrophages and immunoregulatory CD25 T cells, estrogen and progesterone receptors, mRNA, low-density lipoprotein, and cholesterol', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Presence of comedo necrosis', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Safety', 'timeFrame': 'up to 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer in situ', 'ductal breast carcinoma in situ', 'stage IA breast cancer', 'stage IB breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19728082', 'type': 'RESULT', 'citation': 'Garwood ER, Kumar AS, Baehner FL, Moore DH, Au A, Hylton N, Flowers CI, Garber J, Lesnikoski BA, Hwang ES, Olopade O, Port ER, Campbell M, Esserman LJ. Fluvastatin reduces proliferation and increases apoptosis in women with high grade breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):137-44. doi: 10.1007/s10549-009-0507-x.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer.\n\nPURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine differences between measures of cell proliferation (Ki-67) in women with ductal carcinoma in situ (DCIS) or stage I breast cancer receiving neoadjuvant fluvastatin sodium.\n\nSecondary\n\n* Determine whether statin use differentially affects specific types of DCIS/early-stage breast cancer (comedo, estrogen receptor \\[ER\\]-positive, ER-negative).\n* Compare differences between tissue staining of CD68, circulating macrophages, and regulatory T cells in these patients.\n* Assess the feasibility of using inherent susceptibility (mRNA polymerase chain reaction testing) to predict response to statins in these patients.\n\nOUTLINE: This is a randomized, controlled, single-blind, multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms I or II). Patients accrued as control participants are assigned to arm III.\n\n* Arm I: Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral fluvastatin sodium as in arm I at a higher dose.\n* Arm III (control): Patients do not receive fluvastatin sodium. All patients then undergo definitive surgery.\n\nPatients in arms I and II undergo blood collection at baseline and at the time of surgery for biomarker analysis. Patients in arm III undergo blood collection at baseline and then approximately 1 month later. Tissue is collected from patients in all arms at the time of surgery. Blood and tissue samples are examined for biological markers, including Ki-67, C-reactive protein, cleaved caspase 3, HER2, CD68 gene, and estrogen and progesterone receptors by immunohistochemistry. Markers of inflammation (e.g., comedo necrosis macrophages and CD25-positive T cells), low-density lipoprotein, and cholesterol are also analyzed. Serum mRNA is measured by polymerase chain reaction.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ductal carcinoma in situ (DCIS) or stage I breast cancer by stereotactic core or incisional biopsy\n* Planning to undergo surgery in 3-6 weeks\n\n * Patients undergoing re-excision due to evidence of tumor present at surgical margins are eligible\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n* ALT and AST ≤ 10% above upper limit of normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to tolerate statins\n* Willing to undergo 2 blood draws (separated by approximately 3-4 weeks) during study participation (control arm)\n\nPRIOR CONCURRENT THERAPY:\n\n* No other concurrent statins\n* No concurrent chemotherapy\n* No concurrent administration of any of the following:\n\n * Niacin\n * Propranolol\n * Cholestyramine\n * Cyclosporine\n * Digoxin\n * Erythromycin\n * Itraconazole\n * Gemfibrozil\n * Phenytoin\n * Diclofenac\n * Tolbutamide\n * Glyburide\n * Losartan\n * Cimetidine\n * Ranitidine\n * Omeprazole\n * Rifampin\n * Warfarin\n* No initiation of new hormonal therapy during study participation\n* Concurrent participation in other clinical trials (e.g., for DCIS or prevention) is allowed'}, 'identificationModule': {'nctId': 'NCT00416403', 'briefTitle': 'Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000522934'}, 'secondaryIdInfos': [{'id': 'UCSF-047522'}, {'id': 'UCSF-H8409-26206-01'}, {'id': 'MSKCC-06041'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: fluvastatin sodium']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients receive oral fluvastatin sodium as in arm I at a higher dose.', 'interventionNames': ['Drug: fluvastatin sodium']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III', 'description': 'Patients do not receive fluvastatin sodium. breast Cancer surgery only', 'interventionNames': ['Procedure: Breast Cancer Surgery Only - Arm III']}], 'interventions': [{'name': 'fluvastatin sodium', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Breast Cancer Surgery Only - Arm III', 'type': 'PROCEDURE', 'description': 'Breast Cancer Surgery', 'armGroupLabels': ['Arm III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115-6084', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laura J. Esserman, MD, MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}