Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 9:41 PM
Study NCT ID:
NCT00719966
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2008-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2008-07-19', 'studyFirstSubmitQcDate': '2008-07-19', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial dysfunction as a result of aromatase inhibitor therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IA breast cancer', 'stage IB breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer', 'ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy has on blood vessel function.\n\nPURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer.\n\nOUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative).\n\n* Group 1 (hormone receptor-positive): Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.\n* Group 2 (hormone receptor-negative): Patients do not receive adjuvant treatment.\n\nEndothelial function is measured in both groups at baseline and at follow up by the room temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recently diagnosed breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of breast cancer\n* Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer\n* May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast\n* No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection\n* Hormone receptor status meeting 1 of the following criteria:\n\n * Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI)\n * Hormone receptor positive and are not receiving an AI\n\nPATIENT CHARACTERISTICS:\n\n* Postmenopausal\n* No known or symptomatic coronary artery disease\n* No significant co-morbidities, including any of the following conditions:\n\n * Active renal or hepatic disease\n * Known uncontrolled and/or untreated peripheral arterial disease\n * Uncontrolled and/or untreated hypertension\n * Uncontrolled and/or untreated diabetes\n * Uncontrolled and/or untreated hyperlipidemia\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 7 days since prior hormone replacement therapy or hormone-based contraception\n* More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease\n* More than 12 months since prior and no concurrent chemotherapy for this disease\n* No prior bilateral mastectomy'}, 'identificationModule': {'nctId': 'NCT00719966', 'briefTitle': 'Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function', 'orgStudyIdInfo': {'id': 'MC0834'}, 'secondaryIdInfos': [{'id': '06-004006', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 (hormone receptor-positive)', 'description': 'Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.', 'interventionNames': ['Drug: anastrozole', 'Drug: exemestane', 'Drug: letrozole', 'Procedure: assessment of therapy complications']}, {'label': 'Group 2 (hormone receptor-negative)', 'description': 'Patients do not receive adjuvant treatment.', 'interventionNames': ['Procedure: assessment of therapy complications']}], 'interventions': [{'name': 'anastrozole', 'type': 'DRUG', 'description': 'Patients receive aromatase inhibition therapy.', 'armGroupLabels': ['Group 1 (hormone receptor-positive)']}, {'name': 'exemestane', 'type': 'DRUG', 'description': 'Patients receive aromatase inhibition therapy.', 'armGroupLabels': ['Group 1 (hormone receptor-positive)']}, {'name': 'letrozole', 'type': 'DRUG', 'description': 'Patients receive aromatase inhibition therapy.', 'armGroupLabels': ['Group 1 (hormone receptor-positive)']}, {'name': 'assessment of therapy complications', 'type': 'PROCEDURE', 'description': 'Endothelial function is measured', 'armGroupLabels': ['Group 1 (hormone receptor-positive)', 'Group 2 (hormone receptor-negative)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Nicole P. Sandhu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}