Back to results

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

Primary Purpose

Breast Adenocarcinoma, Invasive Breast Carcinoma, Resectable Breast Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Biospecimen Collection

Letrozole

About this trial

This is an interventional health services research trial for Breast Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

SCREENING:
Female >= 18 years
Postmenopausal and suitable to receive aromatase inhibitor as per physician's discretion
Breast imaging showed Breast Imaging Reporting and Data System (BIRADS) >= 4 requiring a biopsy
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
REGISTRATION: 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

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

Sites / Locations

Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (letrozole)

Arm Description

Patients receive letrozole PO 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effects of estrogen deprivation on the immune microenvironment

Estrogen receptor will be evaluated by both biopsy and surgical specimens.

Effects of estrogen deprivation on tumor immune microenvironment

Estrogen receptor will be evaluated by both biopsy and surgical specimens.

Full Information

NCT ID

NCT05447910

First Posted

June 28, 2022

Last Updated

August 15, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05447910

Brief Title

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

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 21, 2022 (Actual)

Primary Completion Date

June 15, 2024 (Anticipated)

Study Completion Date

June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Adenocarcinoma, Invasive Breast Carcinoma, Resectable Breast Carcinoma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (letrozole)

Arm Type

Experimental

Arm Description

Patients receive letrozole PO 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.

Intervention Type

Procedure

Intervention Name(s)

Biospecimen Collection

Other Intervention Name(s)

Biological Sample Collection, Biospecimen Collected, Specimen Collection

Intervention Description

Undergo collection of blood and tissue samples

Intervention Type

Drug

Intervention Name(s)

Letrozole

Other Intervention Name(s)

CGS 20267, Femara

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

Differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive version (vs.) AI-resistant hormone receptor (HR)+ breast cancer

Description

Tissue samples from patients with early-stage hormone receptor-positive HER2-negative breast cancer will be collected to compare differences.

Time Frame

Up to 8 weeks

Secondary Outcome Measure Information:

Title

Effects of estrogen deprivation on the immune microenvironment

Description

Estrogen receptor will be evaluated by both biopsy and surgical specimens.

Time Frame

Up to 8 weeks

Title

Effects of estrogen deprivation on tumor immune microenvironment

Description

Estrogen receptor will be evaluated by both biopsy and surgical specimens.

Time Frame

Up to 8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saranya Chumsri, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224-9980

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Referral Office

Phone

855-776-0015

mayocliniccancerstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Saranya Chumsri, M.D.

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs