Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT00810706
Status:
TERMINATED
Last Update Posted:
2008-12-18
First Post:
2008-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Post-Tamoxifen Exemestane Trial
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'whyStopped': 'Publication of MA17 results (similar trial in the extented adjuvant setting with letrozole)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-16', 'studyFirstSubmitDate': '2008-12-16', 'studyFirstSubmitQcDate': '2008-12-16', 'lastUpdatePostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'effect of exemestane on lipaemic profile', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Aromatase inhibitors', 'Exemestane', 'Tamoxifen', 'Lipids'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '16096437', 'type': 'RESULT', 'citation': 'Markopoulos C, Chrissochou M, Michailidou A, Tzoracoleftherakis E, Xepapadakis G, Papadiamantis J, Misitzis J, Zobolas V, Bafaloukos D, Gogas H. Effect of exemestane on the lipidemic profile of post-menopausal operable breast cancer patients following 5-7 years of adjuvant tamoxifen: preliminary results of the ATENA substudy. Anticancer Drugs. 2005 Sep;16(8):879-83. doi: 10.1097/01.cad.0000173478.12981.e1.'}, {'pmid': '17047401', 'type': 'RESULT', 'citation': 'Markopoulos C, Chrissochou M, Antonopoulou Z, Xepapadakis G, Papadiamantis J, Tzoracoleftherakis E, Gogas H. Duration of tamoxifen effect on lipidemic profile of postmenopausal breast cancer patients following deprivation of treatment. Oncology. 2006;70(4):301-5. doi: 10.1159/000096251. Epub 2006 Oct 12.'}, {'pmid': '19531217', 'type': 'DERIVED', 'citation': 'Markopoulos C, Dafni U, Misitzis J, Zobolas V, Tzoracoleftherakis E, Koukouras D, Xepapadakis G, Papadiamantis J, Venizelos B, Antonopoulou Z, Gogas H. Extended adjuvant hormonal therapy with exemestane has no detrimental effect on the lipid profile of postmenopausal breast cancer patients: final results of the ATENA lipid substudy. Breast Cancer Res. 2009;11(3):R35. doi: 10.1186/bcr2320. Epub 2009 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5 years of adjuvant exemestane versus 5 years of observation in postmenopausal women with operable breast cancer who have received 5-7 years of adjuvant tamoxifen. The primary endpoint for the core protocol is disease-free survival (DFS). Exemestane treatment is planned for 5 years unless disease relapse or excessive toxicity is documented, the patient refuses further treatment or any new anti-cancer therapy is initiated.', 'detailedDescription': "* Patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry.\n* A substudy (ATENA lipid substudy)is designed to evaluate changes in the patients' serum lipid profile during study treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal women only\n* histologically confirmed stage I-IIIA primary adenocarcinoma of the breast\n* estrogen and/or progesterone receptors positive or unknown\n* patients should have undergone surgery with a curative intent\n* patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry\n* Absence of any evidence of local or distant metastatic disease was required prior to randomization\n\nExclusion Criteria:\n\n* DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative'}, 'identificationModule': {'nctId': 'NCT00810706', 'acronym': 'ATENA', 'briefTitle': 'Adjuvant Post-Tamoxifen Exemestane Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Breast Surgeons Society'}, 'officialTitle': 'A Phase III Randomized Parallel-Group Multicenter Trial, Designed to Compare 5 Years of Adjuvant Exemestane Versus 5 Years of Observation in Postmenopausal Women With Operable Breast Cancer Who Have Received 5-7 Years of Adjuvant Tamoxifen.', 'orgStudyIdInfo': {'id': '971-ONC-0028-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1: observation only', 'description': 'Patients have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day). Tamoxifen could have been discontinued up to 6 months prior to study entry.'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: Exemestane', 'description': 'Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment', 'interventionNames': ['Drug: exemestane']}], 'interventions': [{'name': 'exemestane', 'type': 'DRUG', 'otherNames': ['Aromasin'], 'description': 'Patients randomised to receive exemestane (25 mg/day) for 5 years.', 'armGroupLabels': ['2: Exemestane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Hellenic Breast Surgeons Society', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Breast Surgeons Society', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Markopoulos Christos', 'oldOrganization': 'Hellenic Breast Surgeons Society'}}}}