Actively Recruiting
A Randomized Study of Preoperative Letrozole With and Without Simvastatin in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
Led by Emory University · Updated on 2025-05-23
40
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding simvastatin to letrozole is more effective than letrozole alone in stopping the growth of tumor cells in postmenopausal women with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. This early phase I trial aims to measure changes in a tumor growth marker called Ki-67 after 14 days of treatment before surgery. The study also examines immune system changes, pain levels, safety, and various blood and tissue biomarkers. Participants are randomly assigned to one of two groups. One group receives letrozole plus simvastatin orally once daily for 14 days, while the other group receives letrozole alone orally once daily for the same period. Treatment continues unless there is disease progression or unacceptable side effects. After treatment, participants are followed for 30 days to monitor outcomes and safety. During the trial, participants undergo evaluations of tumor samples before and after treatment to assess cell proliferation and immune markers. Blood samples are collected to study inflammatory and immune-related biomarkers and cholesterol levels. Pain is measured using patient-reported questionnaires. Researchers track any side effects and overall safety. The main measure of success is the average change in Ki-67 from before treatment to after 14 days of therapy.
CONDITIONS
Brief Title
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Biopsy confirmed hormone receptor positive, HER2 negative stage I-III invasive breast cancer
- Estrogen or progesterone receptor positive in at least 10% of tumor cells
- HER2 negative by local lab assessment
- Primary tumor size at least 5 mm on breast imaging
- Baseline Ki-67 expression of 10% or higher in tumor tissue
- Postmenopausal women (by surgery, age, or hormone levels)
- ECOG performance status of 0 to 2
- No systemic therapy in the last 3 months
- No statins, fibrates, or ezetimibe in the last 3 months
- No active liver disease
- Hemoglobin 9.0 g/dl or higher
- Absolute neutrophil count 1500/mcL or higher
- Platelets 100,000/mcL or higher
- Total bilirubin no more than twice the institutional upper limit
- AST/ALT no more than three times the institutional upper limit
- Serum creatinine no more than 2 mg/dL or GFR 40 mL/min or higher
- Willing and able to follow study procedures and give informed consent
You will not qualify if you...
- Use of other investigational agents or devices within 3 months
- Allergy to simvastatin or letrozole or similar compounds
- Use of strong CYP3A4 inhibitors or certain other drugs
- Uncontrolled illnesses including infection, heart failure, angina, arrhythmia, substance abuse, or psychiatric conditions limiting compliance
- Significant cardiovascular disease within 3 months prior to treatment
- Additional progressing malignancies requiring treatment except certain skin cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive letrozole with or without simvastatin orally once daily for 14 days before surgery, unless there is disease progression or unacceptable toxicity.
Daily administration for 14 days
Duration - 30 days
Participants are followed for safety and outcomes for 30 days after completing treatment.
1 visit (in-person) within 30 days after treatment
Trial Site Locations
Total: 4 locations
1
Grady Healthcare System
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
R
Ruth L. Sacks, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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