Breast Cancer Clinical Trial
Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer
Summary
This phase II trial examines letrozole in patients with hormone receptor positive, HER2 negative breast cancer that can be removed by surgery (operable). Letrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.
Full Description
PRIMARY OBJECTIVE:
I. To comprehensively evaluate differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive versus (vs.) AI-resistant hormone receptor (HR)+ breast cancer.
SECONDARY OBJECTIVES:
I. To assess the effects of estrogen deprivation on the systemic immune response.
II. To assess the effects of estrogen deprivation on tumor immune microenvironment.
OUTLINE:
Patients receive letrozole orally (PO) once daily (QD) for 2-8 weeks prior to surgery in the absence of disease progression or unacceptable toxicity. Patients then undergo collection of blood and tissue samples.
Eligibility Criteria
Inclusion Criteria:
SCREENING:
Female >= 18 years
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
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There is 1 Location for this study
Jacksonville Florida, 32224, United States More Info
Principal Investigator
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