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Trial Title:
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging
NCT ID:
NCT05700006
Condition:
Breast Neoplasm Female
Arthralgia
Aging
Conditions: Official terms:
Breast Neoplasms
Arthralgia
Aromatase Inhibitors
Conditions: Keywords:
aromatase inhibitor
microbiome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Aromatase inhibitor
Description:
Standard of care anastrozole, exemestane, or letrozole
Arm group label:
Age 65+, AI therapy
Arm group label:
Age under 65, AI therapy
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Norah Henry, MD
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Start date:
July 25, 2022
Completion date:
July 2026
Lead sponsor:
Agency:
University of Michigan
Agency class:
Other
Source:
University of Michigan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700006
