Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

NCT05700006 | Completed

• 2 other identifiers: HUM00208684UMCC 2021.129
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female; Arthralgia; Aging

Keywords

aromatase inhibitor; microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of participants who submit at least 2 out of 3 requested serial stool samples

  12 weeks

Study Arms (3)

Age 65+, AI therapy

Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy

Drug: Aromatase inhibitor

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

Interventions

Aromatase inhibitor DRUG

Standard of care anastrozole, exemestane, or letrozole

Age 65+, AI therapy; Age under 65, AI therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, stool

MeSH Terms

Conditions

Arthralgia

Interventions

Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: July 25, 2022
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)