Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00083993
Status:
TERMINATED
Last Update Posted:
2011-11-08
First Post:
2004-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C401859', 'term': 'temsirolimus'}, {'id': 'D000074584', 'term': 'WW Domain-Containing Oxidoreductase'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D000074583', 'term': 'Short Chain Dehydrogenase-Reductases'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1236}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-07', 'studyFirstSubmitDate': '2004-06-04', 'studyFirstSubmitQcDate': '2004-06-07', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine overall progression free survival.'}], 'secondaryOutcomes': [{'measure': 'To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.'}]}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Breast Neoplasms', 'Neoplasm Metastasis']}, 'referencesModule': {'references': [{'pmid': '23233719', 'type': 'DERIVED', 'citation': 'Wolff AC, Lazar AA, Bondarenko I, Garin AM, Brincat S, Chow L, Sun Y, Neskovic-Konstantinovic Z, Guimaraes RC, Fumoleau P, Chan A, Hachemi S, Strahs A, Cincotta M, Berkenblit A, Krygowski M, Kang LL, Moore L, Hayes DF. Randomized phase III placebo-controlled trial of letrozole plus oral temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol. 2013 Jan 10;31(2):195-202. doi: 10.1200/JCO.2011.38.3331. Epub 2012 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.\n\nIndividual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged greater than 18 years.\n* Postmenopausal subjects\n* Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)\n\nExclusion Criteria:\n\n* Extensive visceral disease\n* Subjects with bone as the only site of disease\n* Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion'}, 'identificationModule': {'nctId': 'NCT00083993', 'briefTitle': 'Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '3066A1-303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Temsirolimus (CCI-779) for 34 months', 'type': 'DRUG'}, {'name': 'Letrozole for 34 months', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 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