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

ClinicalTrials.gov ID: NCT05464810

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05464810
Recruitment status: Recruiting
Study type: Interventional
Phase: Early Phase 1
Lead sponsor: Emory University; Other
Enrollment: 40 participants

Conditions and interventions

Conditions

Interventions

Letrozole Drug
Simvastatin Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2, 2022 (Actual)
Primary completion: Apr 15, 2027 (Estimated)
Completion: Apr 15, 2028 (Estimated)
Last update posted: Jul 17, 2026

2022 – 2028

United States locations

U.S. sites: 4
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Grady Healthcare System	Atlanta	Georgia	30303	Recruiting
Emory University Hospital Midtown	Atlanta	Georgia	30308	Recruiting
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	30322	Recruiting
Emory Saint Joseph's Hospital	Atlanta	Georgia	30342	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05464810, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 17, 2026 · Synced Nov 15, 2026