Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging, Breast Neoplasm Female, Arthralgia

Intervention / Treatment
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* Drug: Aromatase inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age 65+, AI therapy<br>Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy | Drug: Aromatase inhibitor<br>* Standard of care anastrozole, exemestane, or letrozole<br>|
| Age 65+, no endocrine therapy<br>Postmenopausal women age 65 and older who are not starting treatment with any endocrine therapy | |
| Age under 65, AI therapy<br>Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy | Drug: Aromatase inhibitor<br>* Standard of care anastrozole, exemestane, or letrozole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatase inhibitor, microbiome