NCT05464810 is a EARLY_PHASE1 clinical trial of Letrozole in Anatomic Stage I Breast Cancer AJCC v8, sponsored by Emory University.

Who is sponsoring NCT05464810?

NCT05464810 is sponsored by Emory University.

What drugs are being tested in NCT05464810?

Interventions in NCT05464810: Letrozole, Simvastatin.

What condition does NCT05464810 study?

NCT05464810 studies Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Invasive Breast Carcinoma.

Is NCT05464810 still recruiting?

NCT05464810 is currently recruiting now. Last updated 23 May 2025.

Last reviewed 2025-05-23 · How we verify

NCT05464810

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now EARLY_PHASE1 Last updated 23 May 2025

What this trial tests

EARLY_PHASE1 trial testing Letrozole in Anatomic Stage I Breast Cancer AJCC v8 in 40 participants. Currently enrolling.

Timeline

2 September 2022

Primary endpoint
15 April 2026

15 April 2027

Quick facts

Lead sponsor	Emory University
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	2 September 2022
Primary completion	15 April 2026
Estimated completion	15 April 2027
Sites	4 locations across United States

Drugs / interventions tested

Letrozole — full drug profile →
Simvastatin (simvastatin) — full drug profile →

Conditions studied

Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
HER2-Negative Breast Carcinoma — all drugs for HER2-Negative Breast Carcinoma →

Sponsor

Emory University

Who can join

18 and older, female only, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Reprogramming of Lipid Metabolism Mediates Crosstalk, Remodeling, and Intervention of Microenvironment Components in Breast Cancer.
Wang J, Zhang W, Liu C, Wang L, et al · · 2024 · cited 30× · PMID 38481820 · DOI 10.7150/ijbs.92125
Dysregulation of Fatty Acid Metabolism in Breast Cancer and Its Targeted Therapy.
Chang Y, Du R, Xia F, Xu X, et al · · 2024 · cited 5× · PMID 39628960 · DOI 10.2147/bctt.s496322
Lipid metabolism in cancer cells: Its role in hepatocellular carcinoma progression and therapeutic resistance.
Wong TL, Kong Y, Ma S. · · 2025 · cited 2× · PMID 41118283 · DOI 10.1097/hc9.0000000000000837
Clinical significance of lipid pathway-targeted therapy in breast cancer.
Li D, Jin P, Cai Y, Wu S, et al · · 2024 · cited 1× · PMID 39834807 · DOI 10.3389/fphar.2024.1514811
Stress-Inducible Transcription Factor NUPR1 Is Involved in the Inhibitory Effects Exerted by Statins on Insulin Action in ER-Positive Breast Cancer Cells.
Scordamaglia D, Zicarelli A, Cirillo F, Talia M, et al · · 2026 · PMID 41677647 · DOI 10.3390/cells15030284

Verify or expand the search:

Other trials of Letrozole

Trials testing the same drug.

NCT07391774 — Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribocic · Phase 3 · not yet recruiting
NCT07570966 — Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · not yet recruiting
NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT06905301 — Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and W · recruiting
NCT07288359 — Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · recruiting

Other recruiting trials for Anatomic Stage I Breast Cancer AJCC v8

Currently open trials in the same condition.

NCT07443943 — A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive · Phase 2 · recruiting
NCT07158021 — Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial · Phase 2 · recruiting
NCT06324240 — Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Canc · Phase 1 · recruiting
NCT07407920 — Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial · Phase 2 · active not recruiting
NCT06876714 — ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathol · Phase 3 · recruiting

Other Emory University trials

Trials by the same sponsor.

NCT06143345 — HIIT in Isolated IFG: A Proof-of-Concept Study · NA · withdrawn
NCT07189819 — Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait · NA · not yet recruiting
NCT06451055 — Low-calorie Diet in Isolated Impaired Fasting Glucose · NA · not yet recruiting
NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I · Phase 2 · recruiting
NCT06708351 — Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05464810 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 23 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05464810.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing