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Completed

NCT Number: NCT05700006

Pilot Observational Study 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatase Inhibitor

Drug

Standard of care anastrozole, exemestane, or letrozole

Primary outcomes

  1. Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections

    Time frame: 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 outcomes

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

    Time frame: 12 weeks

    To assess feasibility of enrolling patients with breast cancer in a study that collects serial stool samples

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: BETA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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