Breast Neoplasm FemaleBETANCT05700006
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging
An observational study of Breast Neoplasm Female and Arthralgia, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Arthralgia, Aging
- What is being tested?
- Aromatase inhibitor
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 26 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Distant metastatic disease
- Prior aromatase inhibitor therapy except in the context of fertility treatment.
- Use of exogenous estrogen supplementation other than vaginal estrogen preparations.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: An Observational Study of Women With Breast Cancer 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.
- Conditions
- Breast Neoplasm Female, Arthralgia, Aging
- Being tested
- Aromatase inhibitor
- Keywords
- aromatase inhibitor, microbiome
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase inhibitorDrug
Standard of care anastrozole, exemestane, or letrozole
| Study group | Role | What they receive |
|---|---|---|
| Age 65+, AI therapy | Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy Receives: Drug: Aromatase inhibitor | |
| 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 Receives: Drug: Aromatase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start25 Jul 2022
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N. Lynn Henry, University of Michigan
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700006
- Sponsor's protocol ID
- HUM00208684
- Other IDs
- UMCC 2021.129
- Acronym
- BETA
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging
- ClinicalTrials.gov ID
- NCT05700006
- Acronym / sponsor ID
- BETA / HUM00208684
- Conditions
- Breast Neoplasm Female, Arthralgia, Aging
- Keywords
- aromatase inhibitor, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age 65+, AI therapy | – | Drug: Aromatase inhibitorPostmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy |
| 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 | – | Drug: Aromatase inhibitorPostmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (3 listed)
- Distant metastatic disease
- Prior aromatase inhibitor therapy except in the context of fertility treatment.
- Use of exogenous estrogen supplementation other than vaginal estrogen preparations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatase inhibitorStandard of care anastrozole, exemestane, or letrozole | Drug | Age 65+, AI therapy, Age under 65, AI therapy |
Primary outcome
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
1 secondary outcome
Percentage of participants who submit at least 2 out of 3 requested serial stool samples
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norah L Henry, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female and Arthralgia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of particpants in the 65+ AI therapy group who complete 3 serial blood collections and 5 serial ePRO collections (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.