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NCT05464810 · ClinicalTrials.gov registry record · Early Phase 1
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
A Early Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT05464810 is a Early Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 40 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT05464810, a Early Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Simvastatin
Study Locations (4)
Georgia
- Grady Healthcare System - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2027-04-15 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05464810
The ClinicalTrials.gov registry entry for NCT05464810 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (87% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Letrozole is the first listed.
NCT05464810 reports 4 study locations spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT05464810 about?
NCT05464810 is a clinical study titled "Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer". 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...
What is the current status of trial NCT05464810?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2022-09-02. Estimated completion is 2027-04-15.
What conditions does trial NCT05464810 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Invasive Breast Carcinoma, HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT05464810?
The interventions under investigation include: Letrozole (DRUG), Simvastatin (DRUG).
Who is sponsoring clinical trial NCT05464810?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464810 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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