Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-29 @ 6:15 AM
Study NCT ID:
NCT00070057
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2003-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive 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': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2003-10-03', 'studyFirstSubmitQcDate': '2003-10-06', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in aromatase activity levels', 'timeFrame': 'From baseline to post-surgery'}], 'secondaryOutcomes': [{'measure': 'Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry', 'timeFrame': 'From baseline to post-treatment'}, {'measure': 'Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens', 'timeFrame': 'At post-treatment/surgery'}, {'measure': 'Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels', 'timeFrame': 'At post-treatment/surgery'}]}, 'conditionsModule': {'conditions': ['Stage I Breast Cancer', 'Stage II Breast Cancer', 'Stage IIIA Breast Cancer', 'Stage IIIB Breast Cancer', 'Stage IIIC Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.\n\nSECONDARY OBJECTIVES:\n\nI. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.\n\nII. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE\\_2 levels in these patients.\n\nIII. Determine whether any observed biological effect of this drug is dose-dependent in these patients.\n\nIV. Identify collateral targets (COX-2-independent) of this drug in these patients.\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.\n\nArm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.\n\nArm II: Patients receive a higher dose of oral celecoxib as in arm I.\n\nArm III: Patients do not receive treatment.\n\nAll patients undergo definitive surgery.\n\nPROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed invasive breast carcinoma\n\n * Tumor at least 1 cm by radiologic estimate or physical exam\n * No disease limited to ductal carcinoma in situ only\n* Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center\n* Hormone receptor status:\n\n * Not specified\n* Female\n* Postmenopausal as defined by at least 1 of the following:\n\n * No menstrual period within the past 12 months\n * Prior bilateral oophorectomy\n* No known liver disease\n* No renal insufficiency\n* No congestive heart failure\n* No coronary artery disease\n* No history of documented peptic ulcer disease\n* No gastritis\n* No medical condition that would preclude definitive surgery\n* No allergy to NSAIDs or sulfa-containing drugs\n* No connective tissue diseases, including any of the following:\n\n * Systemic lupus erythematosus\n * Reynaud's disease\n * Scleroderma\n* More than 3 months since prior chemotherapy\n* More than 2 weeks since prior hormone replacement therapy\n* More than 2 weeks since prior tamoxifen\n* More than 2 weeks since prior aromatase inhibitors\n* More than 2 weeks since prior raloxifene\n* More than 2 weeks since prior steroids\n* More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)\n* More than 1 week since prior cyclooxygenase (COX)-2 inhibitors\n* No concurrent warfarin\n* No concurrent thiazide or loop diuretics\n* No concurrent COX-2 inhibitors\n* No concurrent NSAIDs"}, 'identificationModule': {'nctId': 'NCT00070057', 'briefTitle': 'Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-01441'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01441', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000329919'}, {'id': 'MSKCC-03027', 'type': 'OTHER', 'domain': 'Memorial Sloan-Kettering Cancer Center'}, {'id': 'N01-CN-35112', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'P30CA008748', 'link': 'https://reporter.nih.gov/quickSearch/P30CA008748', 'type': 'NIH'}, {'id': 'N01CN35112', 'type': 'OTHER_GRANT', 'domain': 'US NIH Grant/Contract Award Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (celecoxib)', 'description': 'Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.', 'interventionNames': ['Drug: celecoxib', 'Procedure: therapeutic conventional surgery', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (high-dose celecoxib)', 'description': 'Patients receive a higher dose of oral celecoxib as in arm I.', 'interventionNames': ['Drug: celecoxib', 'Procedure: therapeutic conventional surgery', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm III (surgery)', 'description': 'Patients do not receive treatment. All patients undergo surgery.', 'interventionNames': ['Procedure: therapeutic conventional surgery', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex', 'SC-58635'], 'description': 'Given orally', 'armGroupLabels': ['Arm I (celecoxib)', 'Arm II (high-dose celecoxib)']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgery', 'armGroupLabels': ['Arm I (celecoxib)', 'Arm II (high-dose celecoxib)', 'Arm III (surgery)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (celecoxib)', 'Arm II (high-dose celecoxib)', 'Arm III (surgery)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (celecoxib)', 'Arm II (high-dose celecoxib)', 'Arm III (surgery)']}]}, 'contactsLocationsModule': {'locations': [{'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': 'Elisa Port', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}