Clinical trial · Observational
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging
An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aging | — | UNRESOLVED | — |
| Arthralgia | — | UNRESOLVED | — |
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase inhibitor | Drug | Aromatase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Age 65+, AI therapy
- description
- Postmenopausal women age 65 and older who are starting treatment with standard of care aromatase inhibitor therapy
- interventionNames
- Drug: Aromatase inhibitor
- label
- Age 65+, no endocrine therapy
- description
- Postmenopausal women age 65 and older who are not starting treatment with any endocrine therapy
- label
- Age under 65, AI therapy
- description
- Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy
- interventionNames
- Drug: Aromatase inhibitor
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available