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| ID | Type | Description | Link |
|---|---|---|---|
| UMCC 2021.129 | Other Identifier | Rogel Cancer Center |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 65+, AI therapy | Postmenopausal 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 | Postmenopausal women age less than 65 who are starting treatment with standard of care aromatase inhibitor therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatase inhibitor | Drug | Standard of care anastrozole, exemestane, or letrozole |
|
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Norah L Henry, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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Whole blood, stool
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |