Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:40 AM
Study NCT ID:
NCT05700006
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2023-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047072', 'term': 'Aromatase Inhibitors'}], 'ancestors': [{'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections', 'timeFrame': '1 year', 'description': 'To assess feasibility of enrolling patients 65 and older in a study that collects serial blood samples and electronic patient-reported outcomes'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants who submit at least 2 out of 3 requested serial stool samples', 'timeFrame': '12 weeks', 'description': 'To assess feasibility of enrolling patients with breast cancer in a study that collects serial stool samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aromatase inhibitor', 'microbiome'], 'conditions': ['Breast Neoplasm Female', 'Arthralgia', 'Aging']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot observational study is to learn about the feasibility of collecting patient-reported data and stool and blood samples from patients age 65 and older treated with aromatase inhibitor therapy for breast cancer. Participants will be treated with standard of care aromatase inhibitor therapy and will undergo serial phlebotomy, complete patient-reported questionnaires, and submit serial stool samples.\n\nThe main exploratory translational questions it aims to obtain preliminary data for are:\n\n* What are the effects of aromatase inhibitor therapy on biomarkers of aging?\n* What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer or who are at high risk for breast cancer who are starting treatment with aromatase inhibitor therapy as standard of care for treating breast cancer or for chemoprevention will be eligible. In addition, women age 65 and older with breast cancer or at high risk for developing breast cancer who are not going to receive treatment with endocrine therapy are eligible for the control cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Female gender.\n* Cohort 1: Age 65 or greater. Cohort 2: Age younger than 65 years\n* Cohort 1 Participants (starting AI therapy): Histologically proven stage 0-III carcinoma of the breast or at high risk for development of breast cancer who are planning to undergo treatment with neoadjuvant or adjuvant aromatase inhibitor therapy (anastrozole, letrozole, or exemestane).\n* Cohort 1 Controls (no endocrine therapy): Histologically proven stage 0-III carcinoma of the breast or high risk for development of breast cancer and who are not planning to undergo treatment with any endocrine therapy (AI or tamoxifen).\n* Participants Cohort 2 (starting AI therapy): Histologically proven stage 0-III carcinoma of the breast or at high risk for development of breast cancer who are planning to undergo treatment with neoadjuvant or adjuvant aromatase inhibitor therapy (anastrozole, letrozole, or exemestane).\n* Concurrent treatment with GnRHa therapy, radiation therapy, CDK4/6 inhibitor, bisphosphonate, PARP inhibitor, and/or anti-HER2 therapy is permitted. Prior tamoxifen is permitted.\n* The patient is aware of the nature of her diagnosis, understands the study requirements, risks, and discomforts, and is able and willing to sign an informed consent form.\n* Able to read and understand English.\n\nExclusion Criteria\n\n* Distant metastatic disease\n* Prior aromatase inhibitor therapy except in the context of fertility treatment.\n* Use of exogenous estrogen supplementation other than vaginal estrogen preparations.'}, 'identificationModule': {'nctId': 'NCT05700006', 'acronym': 'BETA', 'briefTitle': 'Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging', 'orgStudyIdInfo': {'id': 'HUM00208684'}, 'secondaryIdInfos': [{'id': 'UMCC 2021.129', 'type': 'OTHER', 'domain': 'Rogel Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age 65+, AI therapy', 'description': 'Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy', 'interventionNames': ['Drug: Aromatase inhibitor']}, {'label': 'Age 65+, no endocrine therapy', 'description': 'Postmenopausal women age 65 and older who are not starting treatment with any endocrine therapy'}, {'label': 'Age under 65, AI therapy', 'description': 'Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy', 'interventionNames': ['Drug: Aromatase inhibitor']}], 'interventions': [{'name': 'Aromatase inhibitor', 'type': 'DRUG', 'description': 'Standard of care anastrozole, exemestane, or letrozole', 'armGroupLabels': ['Age 65+, AI therapy', 'Age under 65, AI therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Norah L Henry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'N. Lynn Henry', 'investigatorAffiliation': 'University of Michigan'}}}}