Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

Active, not recruiting

• Conditions: Breast Neoplasm Female; Arthralgia; Aging
• Interventions: Drug: Aromatase inhibitor

• Registration Number: NCT05700006
• Lead Sponsor: University of Michigan

Brief Summary

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.

The main exploratory translational questions it aims to obtain preliminary data for are:

* What are the effects of aromatase inhibitor therapy on biomarkers of aging?

* What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-25
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age 65+, AI therapy	Aromatase inhibitor	Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy
Age under 65, AI therapy	Aromatase inhibitor	Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy

Primary Outcome Measures

Name	Time	Method
Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections	1 year	To assess feasibility of enrolling patients 65 and older in a study that collects serial blood samples and electronic patient-reported outcomes

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who submit at least 2 out of 3 requested serial stool samples	12 weeks	To assess feasibility of enrolling patients with breast cancer in a study that collects serial stool samples

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States