Clinical trialNCT05464810RecruitingEarly phase 1Interventional

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

SponsorEmory UniversityEnrollment40Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Negative Breast CarcinomaHormone Receptor-Positive Breast CarcinomaInvasive Breast Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Ruth L. Sacks, MD
Emory University Hospital/Winship Cancer Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Emory Saint Joseph'S Hospital
Atlanta, Georgia, United States
Ruth L. Sacks, MD
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Ruth L. Sacks, MD
Recruiting
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Ruth L. Sacks, MD
Recruiting
Grady Healthcare System
Atlanta, Georgia, United States
Ruth Sacks, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Letrozole →Simvastatin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Sept 2022
Primary completion: 15 Apr 2027
Completion: 15 Apr 2028
Last update posted: 17 Jul 2026
Registered enrollment: 40
Registry id: NCT05464810

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.