Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

NCT ID: NCT05700006

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2026-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Age 65+, AI therapy

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

Aromatase inhibitor

Intervention Type: DRUG

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

No interventions assigned to this group

Age under 65, AI therapy

Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy

Aromatase inhibitor

Intervention Type: DRUG

Standard of care anastrozole, exemestane, or letrozole

Interventions

Aromatase inhibitor

Standard of care anastrozole, exemestane, or letrozole

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

N. Lynn Henry

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norah L Henry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 2021.129

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00208684

Identifier Type: -

Identifier Source: org_study_id