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

NCT05447910 | Terminated DMC

• 2 other identifiers: 21-003046NCI-2022-04802
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Adenocarcinoma; Invasive Breast Carcinoma; Resectable Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effects of estrogen deprivation on the immune microenvironment

  Up to 8 weeks

• Effects of estrogen deprivation on tumor immune microenvironment

  Up to 8 weeks

Study Arms (1)

Patients with early-stage hormone receptor-positive HER2-negative breast cancer receiving letrozole

Patients undergo collection of blood and tissue samples prior to beginning treatment with letrozole and at least two weeks after the start of letrozole treatment, but prior to surgery.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and tissue samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Patients with early-stage hormone receptor-positive HER2-negative breast cancer receiving letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early-stage hormone receptor-positive HER2-negative breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples store for future research with consent of participants

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Saranya Chumsri, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: July 21, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)