Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging (BETA)

An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging

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.

Study Overview

• Status: Completed
• Conditions: Arthralgia; Aging; Breast Neoplasm Female
• Intervention / Treatment: Drug: Aromatase inhibitor

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria

• Female gender.
• Cohort 1: Age 65 or greater. Cohort 2: Age younger than 65 years
• 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).
• 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).
• 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).
• Concurrent treatment with GnRHa therapy, radiation therapy, CDK4/6 inhibitor, bisphosphonate, PARP inhibitor, and/or anti-HER2 therapy is permitted. Prior tamoxifen is permitted.
• 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.
• Able to read and understand English.

Exclusion Criteria

• Distant metastatic disease
• Prior aromatase inhibitor therapy except in the context of fertility treatment.
• Use of exogenous estrogen supplementation other than vaginal estrogen preparations.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age 65+, AI therapy; Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy	Drug: Aromatase inhibitor; Standard of care anastrozole, exemestane, or letrozole
Age 65+, no endocrine therapy; Postmenopausal women age 65 and older who are not starting treatment with any endocrine therapy
Age under 65, AI therapy; Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy	Drug: Aromatase inhibitor; Standard of care anastrozole, exemestane, or letrozole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Norah L Henry, MD, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): February 26, 2026
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: microbiome; aromatase inhibitor
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arthralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Estrogen Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Aromatase Inhibitors
• Other Study ID Numbers: HUM00208684; UMCC 2021.129 (Other Identifier: Rogel Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No