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

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05700006

Collaborator

(none)

100

Enrollment

Location

47.2

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female Arthralgia Aging	Drug: Aromatase inhibitor

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 25, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

N. Lynn Henry, Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT05700006

Other Study ID Numbers:

HUM00208684
UMCC 2021.129

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by N. Lynn Henry, Professor, University of Michigan

aromatase inhibitor

microbiome

Additional relevant MeSH terms:

Breast Neoplasms

Arthralgia

Aromatase Inhibitors

Study Results

No Results Posted as of Jan 26, 2023