Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer

Invasive Breast Carcinoma Clinical Trial

Official title:

Comprehensive Single-Cell Transcriptional Analysis of Aromatase Inhibitor-Resistant Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447910
• Other study ID #: 21-003046
• Secondary ID: NCI-2022-04802
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial examines letrozole in patients with newly diagnosed hormone receptor-positive HER2-negative invasive 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Adenocarcinoma
• Breast Neoplasms
• Carcinoma
• Invasive Breast Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue samples

Drug:
• Letrozole
Given PO

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive version (vs.) AI-resistant hormone receptor (HR)+ breast cancer	Tissue samples from patients with early-stage hormone receptor-positive HER2-negative breast cancer will be collected to compare differences.	Up to 8 weeks
Secondary	Effects of estrogen deprivation on the immune microenvironment	Estrogen receptor will be evaluated by both biopsy and surgical specimens.	Up to 8 weeks
Secondary	Effects of estrogen deprivation on tumor immune microenvironment	Estrogen receptor will be evaluated by both biopsy and surgical specimens.	Up to 8 weeks

External Links

•   Mayo Clinic Clinical Trials