The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.
The study will enroll mainly subjects with estrogen receptor positive breast cancer that have completed surgery and radiation therapy to remove the tumor(s) and have not yet started standard treatment endocrine therapy. There is one group of subjects who have not been diagnosed with cancer. The information learned from this study will help doctors understand more about how the immune system responds to endocrine therapy for early stage breast cancer in people who are estrogen receptor positive with the goal of developing improved therapies that harness the immune system.
Study Type
OBSERVATIONAL
Enrollment
68
Duke University Medical Center
Durham, North Carolina, United States
Changes in estrogen levels in response to adjuvant endocrine therapy.
Phenotypic and functional characterization of T cell and B cell populations will be performed on peripheral blood mononuclear cells.
Time frame: 2 years
Changes in regulatory T cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assessed at each time point to understand the impact of endocrine therapy on regulatory T cells.
Time frame: Through study completion, approximately 1 year.
Changes in T cell activation/ V cell activation in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell activation/ V cell activation.
Time frame: Through study completion, approximately 1 year.
Changes in T cell exhaustion in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assessed at each time point to understand the impact of endocrine therapy in T cell exhaustion.
Time frame: Through study completion, approximately 1 year.
Changes in myeloid-derived suppressor cells in premenopausal vs postmenopausal women treated with aromatase inhibitors.
Blood will be assess at each time point to understand the impact of endocrine therapy on myeloid-derived suppressor cells.
Time frame: Through study completion, approximately 1 year.
Changes in physical manifestations with the Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue survey to measure response to adjuvant endocrine therapy.
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PROMIS Fatigue quality of life survey will be given at each time point.
Time frame: Through study completion, approximately 1 year.
Changes in inflammatory markers with Patient-Reported Arthralgia Inventory (PRAI) to measure response to adjuvant endocrine therapy.
16-item Patient-Reported Arthralgia Inventory (PRAI) quality of life survey will be given at each time point.
Time frame: Through study completion, approximately 1 year.
Assess changes in RNA express in response to endocrine therapy.
RNA expression of PMBCs will be performed to assess changes in gene expression due to endocrine therapy.
Time frame: Through study completion, approximately 1 year.