RecruitingEarly Phase 1NCT05464810

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

A Randomized Window of Opportunity Study of Preoperative Letrozole and Simvastatin Versus Letrozole Alone in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Sponsor

Emory University

Enrollment

40 participants

Start Date

Sep 2, 2022

Study Type

INTERVENTIONAL

Conditions

HER2-Negative Breast Carcinoma Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Hormone Receptor-Positive Breast Carcinoma Invasive Breast Carcinoma

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding simvastatin — a common cholesterol-lowering drug — to standard letrozole hormone therapy improves outcomes for women with early-stage hormone receptor-positive, HER2-negative breast cancer. Statins may have anti-cancer properties in addition to their cholesterol benefits. **You may be eligible if...** - You are 18 or older with stage I–III hormone receptor-positive, HER2-negative invasive breast cancer confirmed by biopsy - Your estrogen or progesterone receptors are positive (10% or more of cells) - You are able to take oral medications **You may NOT be eligible if...** - You have metastatic (stage IV) breast cancer - You cannot take letrozole or statins due to allergies or drug interactions - You have serious liver disease (statins can affect liver function) - You are premenopausal and not receiving ovarian suppression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.