Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT05464810

Letrozole With and Without Simvastatin for the Treatment of 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

240 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

This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.

CONDITIONS

Official Title

Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Biopsy confirmed hormone receptor positive, HER2 negative invasive breast cancer stage I-III
  • Estrogen receptor and/or progesterone receptor positive defined as 10% or more of cells positive by IHC
  • HER2 negative defined by IHC 0, 1+, or 2+ and non-amplified ISH
  • Primary tumor size at least 5 mm on breast imaging
  • Baseline Ki-67 expression of 10% or higher on tumor tissue
  • Postmenopausal women (prior bilateral oophorectomy or age 55 or older or amenorrheic for 12+ months with hormone levels in postmenopausal range)
  • ECOG performance status 0 to 2
  • No systemic therapy within 3 months before enrollment
  • No statins, fibrates, or ezetimibe within 3 months before enrollment
  • No active liver disease
  • Hemoglobin 9.0 g/dl or higher within 14 days before treatment
  • Absolute neutrophil count 1,500/mcL or higher within 14 days before treatment
  • Platelets 100,000/mcL or higher within 14 days before treatment
  • Total bilirubin no more than 2 times institutional upper limit within 14 days before treatment
  • AST/ALT no more than 3 times institutional upper limit within 14 days before treatment
  • Serum creatinine 2 mg/dL or less or glomerular filtration rate 40 mL/min or more within 14 days before treatment
  • Willing and able to follow study visits, drug plan, tests, procedures, and restrictions
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Receiving any other investigational agents or devices within 3 months before first study drug dose
  • History of allergic reactions to simvastatin or letrozole or similar compounds
  • Taking strong CYP3A4 inhibitors or certain other drugs (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, posaconazole, voriconazole, protease inhibitors, telithromycin, cobicistat products, cyclosporine, danazol, gemfibrozil)
  • Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, substance abuse, or psychiatric/social conditions limiting study compliance
  • Significant cardiovascular disease within 3 months before study therapy (e.g., recent heart attack, thromboembolism, angina needing treatment, severe congestive heart failure, uncontrolled high blood pressure despite medication)
  • Known additional progressing malignancy requiring active treatment except certain treated skin cancers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

R

Ruth L. Sacks, MD

CONTACT

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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Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer | DecenTrialz