Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT00016432
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2001-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
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': 'C056516', 'term': 'exemestane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1598}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2001-05-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Death from any cause'}, {'measure': 'Time to treatment failure', 'timeFrame': 'time from randomization to recurrence or contralateral second primary cancer'}, {'measure': 'Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement', 'timeFrame': 'measurements taken at regular intervals from randomization through 6 years following randomiztion'}]}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '18332472', 'type': 'RESULT', 'citation': 'Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, Eisen A, Fehrenbacher L, Farrar WB, Atkins JN, Pajon ER, Vogel VG, Kroener JF, Hutchins LF, Robidoux A, Hoehn JL, Ingle JN, Geyer CE Jr, Costantino JP, Wolmark N. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008 Apr 20;26(12):1965-71. doi: 10.1200/JCO.2007.14.0228. Epub 2008 Mar 10.'}, {'type': 'RESULT', 'citation': 'Mamounas E, Jeong J-H, Wickerham L, et al.: Benefit from exemestane (EXE) as extended adjuvant therapy after 5 years of tamoxifen (TAM): intent-to-treat analysis of NSABP B-33. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-49, S22, 2006.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer.\n\nPURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer.\n* Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients.\n* Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients.\n* Evaluate the quality of life of a subset of these patients.\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral exemestane daily for 5 years.\n* Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years.\n\nQuality of life is assessed at baseline and then every 6 months for 5.5 years.\n\nPatients are followed every 6 months for 6 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis\n\n * Tumor confined to the breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0) (stage I-IIIA)\n * No ipsilateral lymph nodes clinically fixed to one another or to other structures (N2 disease) at time of original diagnosis\n* Prior surgical resection, including 1 of the following:\n\n * Total mastectomy and axillary dissection (modified radical mastectomy) OR\n * Lumpectomy and axillary dissection\n\n * Prior post-lumpectomy breast radiotherapy required\n * Prior sentinel node biopsy allowed with the exception of the following:\n\n * If any sentinel node is histologically positive by hematoxylin and eosin (H \\& E) OR histologically suspicious on H \\& E and confirmed positive by immunohistochemistry then the patient must have a complete axillary dissection\n * Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ\n* Currently disease free\n* Previously treated with tamoxifen for 57-66 months\n\n * Completed tamoxifen within the past 180 days\n* No bilateral malignancy or mass in the opposite breast suspicious for malignancy unless biopsy proven negative\n* No local, regional, or distant recurrence of disease or second primary breast malignancy (including contralateral breast cancer)\n* No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall \\[complete fixation\\], peau d'orange, or skin edema of any magnitude)\n\n * Tethering or dimpling of the skin or nipple inversion allowed\n* Current skeletal pain allowed if a bone scan and/or radiologic exam is negative for metastatic disease\n* Hormone receptor status:\n\n * Primary tumor estrogen receptor (ER) positive AND/OR\n * Progesterone receptor positive\n * Borderline ER positive tumors allowed if previously treated with tamoxifen\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Postmenopausal\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Postmenopausal, defined as 1 of the following:\n\n * Prior bilateral oophorectomy\n * Absence of spontaneous menstrual cycle for more than 1 year\n * Follicle-stimulating hormone within the postmenopausal range if under 55 and had a prior hysterectomy without a bilateral oophorectomy\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* At least 10 years\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin normal\n\nHepatic:\n\n* Bilirubin less than 2 times upper limit of normal (ULN)\n* SGOT or SGPT no greater than 2.5 times ULN\n* Alkaline phosphatase less than 2 times ULN\n* No systemic hepatic disease that would preclude study participation\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n* No systemic renal disease that would preclude study participation\n\nCardiovascular:\n\n* No systemic cardiovascular disease that would preclude study participation\n\nOther:\n\n* No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, surgically treated carcinoma in situ of the cervix, or surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast\n* No nonmalignant systemic disease that would preclude study participation\n* No psychiatric or addictive disorder that would preclude informed consent\n* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior adjuvant chemotherapy allowed if administered concurrently with or prior to tamoxifen\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin-releasing hormone, oral contraceptives, selective estrogen-receptor modulators, or dehydroepiandrosterone (DHEA)\n\n * Estring or estrogen vaginal cream at 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week allowed\n* No other concurrent systemic hormonal therapy (e.g., tamoxifen or raloxifene)\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Prior post-mastectomy loco-regional radiotherapy or post-lumpectomy regional radiotherapy allowed\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* Prior participation in other adjuvant NSABP study allowed if study was reported in peer-review publication or tamoxifen was not a study drug\n* Concurrent bisphosphonates or calcitonin for prevention or treatment of osteoporosis allowed\n* Concurrent statins (simvastatin, pravastatin, fluvastatin, atorvastatin, or lovastatin) or other drugs to control lipid levels allowed"}, 'identificationModule': {'nctId': 'NCT00016432', 'briefTitle': 'Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen', 'organization': {'class': 'NETWORK', 'fullName': 'NSABP Foundation Inc'}, 'officialTitle': 'A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy', 'orgStudyIdInfo': {'id': 'NSABP B-33'}, 'secondaryIdInfos': [{'id': 'CDR0000068640'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Exemestane', 'interventionNames': ['Drug: exemestane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'exemestane', 'type': 'DRUG', 'description': '25 mg for 5 years', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Institute of Huntsville', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Greater Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health Western Division Cancer Research Group', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Institute', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of the Desert', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '95816', 'city': 'Sacramento', 'state': 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