Clinical trial NCT05447910: Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer
Official title: Comprehensive Single-Cell Transcriptional Analysis of Aromatase Inhibitor-Resistant Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Adenocarcinoma
Invasive Breast Carcinoma
Resectable Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early-stage hormone receptor-positive HER2-negative breast cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive version (vs.) AI-resistant hormone receptor (HR)+ breast cancer
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Effects of estrogen deprivation on the immune microenvironment
timeFrame: Up to 8 weeks
measure: Effects of estrogen deprivation on tumor immune microenvironment
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Saranya Chumsri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: