Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

Aging Clinical Trial

— BETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700006
• Other study ID #: HUM00208684
• Secondary ID: UMCC 2021.129
• Status: Recruiting
• Start date: July 25, 2022
• Est. completion date: July 2026

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Norah L Henry, MD, PhD
• Phone: 800-865-1125
• Email: CancerAnswerLine[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Arthralgia
• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Drug:
• Aromatase inhibitor
Standard of care anastrozole, exemestane, or letrozole

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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