Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01072318
Status:
UNKNOWN
Last Update Posted:
2010-02-22
First Post:
2010-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
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': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 495}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-18', 'studyFirstSubmitDate': '2010-02-14', 'studyFirstSubmitQcDate': '2010-02-18', 'lastUpdatePostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival rate', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Disease free survival rate', 'timeFrame': '12 months, 24 months'}, {'measure': 'Distant disease free survival rate', 'timeFrame': '12 months, 24 months, 36 months'}, {'measure': 'Overall survival rate', 'timeFrame': '12, 24, 36 months'}, {'measure': 'Toxicity was assessed by NCI-CTC version 3.0', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'extended adjuvant hormonal therapy', 'letrozole', 'Toremifene'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene', 'detailedDescription': '1. Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene\n2. Secondary purpose\n\n * To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene.\n\n 1. Disease Free Survival rate(DFS)-12 months, 24 months\n 2. Distant disease free survival rate(DDFS), Overall Survival(OS)\n * 12 months, 24 months, 36 months c. safety\n * Change of lipid profiles\n * Mortality and morbidity due to Cardiovascular disease\n * Incidence of Fracture\n * Change of Bone density\n * Common toxic effect'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.\n2. Removed the breast cancer histologically or cytologically\n3. No evidence of breast cancer in controlateral breast\n4. No evidence of metastasis\n5. Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months\n6. Postmenopausal state was defined the following conditions, at least one of a, b\n\n 1. Serum FSH ≥ 30 mIU/mL\n 2. Amenorrhea ≥ 1 year\n7. Estrogen receptor(+) or Progesterone receptor(+)\n8. No Evidence of Recurrence\n\nExclusion Criteria:\n\n1. Patient with hormone receptor negative\n2. Patients with malignancies\n3. Patients with other aromatase inhibitor and chemotherapy\n4. Patients with Other hormone therapy and Hormonal replacement therapy\n5. Patients with Hormone replacement therapy during taking Toremifene\n6. Estimated life expectancy of \\<12 months\n7. WBC\\<3,000/mm3 or Platelet count\\<100,000/mm3\n8. AST and/or ALT ≥2xUNL\n9. Alkaline phosphatase ≥2xUNL'}, 'identificationModule': {'nctId': 'NCT01072318', 'acronym': 'LEXTOP', 'briefTitle': 'Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene', 'organization': {'class': 'OTHER', 'fullName': 'Korean Breast Cancer Study Group'}, 'officialTitle': 'Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene', 'orgStudyIdInfo': {'id': 'KBCSG007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole, DFS', 'description': 'Efficacy evaluation of extended letrozole after 5 year fareston use', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'Letrozole 2.5mg', 'armGroupLabels': ['Letrozole, DFS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sei-Hyun Ahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Asan medical center, South Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Breast Cancer Study Group', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sei-Hyun Ahn', 'oldOrganization': 'Asan medical center'}}}}