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Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
NCT05464810 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05464810 reports 4 study locations spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05464810?
The interventions under investigation include: Letrozole (DRUG), Simvastatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05464810?
This trial is sponsored by Emory University, which has 1,434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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