Breast Adenocarcinoma, Invasive Breast Carcinoma, Resectable Breast Carcinoma
Conditions
Brief summary
The purpose of this study is to study to collect tissue samples from patients with early stage hormone receptor-positive HER2-negative breast cancer.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood and tissue samples
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal and suitable to receive aromatase inhibitor as per physician's discretion * Histologically confirmed un-resected operable invasive adenocarcinoma of the breast ≥ 0.5 cm with estrogen receptor (ER) and/or progesterone receptor (PR) positive ≥ 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression * Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included * Willing and able to provide research tissue samples * Willing and able to provide research blood samples
Exclusion criteria
* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids * NOTE: Must be off systemic steroids at least 14 days prior to pre-registration. However, topical steroids, inhalants or steroid eye drops are permitted * Known history of active autoimmune disease that has required systemic treatment within =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive version (vs.) AI-resistant hormone receptor (HR)+ breast cancer | Up to 8 weeks | Tissue samples from patients with early-stage hormone receptor-positive HER2-negative breast cancer will be collected to compare differences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of estrogen deprivation on the immune microenvironment | Up to 8 weeks | Estrogen receptor will be evaluated by both biopsy and surgical specimens. |
| Effects of estrogen deprivation on tumor immune microenvironment | Up to 8 weeks | Estrogen receptor will be evaluated by both biopsy and surgical specimens. |
Countries
United States
Outcome results
None listed