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
Sponsored by
About this trial
This is an interventional health services research trial for Breast Adenocarcinoma
Eligibility Criteria
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
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
No
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
No
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
Email
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
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