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Aromatase Inhibitor

Letrozole + Simvastatin for Breast Cancer

Phase < 1

Recruiting

Led By Ruth L Sacks

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No active liver disease

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing whether adding simvastatin to letrozole may stop the growth of cancer cells more effectively than letrozole alone.

Who is the study for?

This trial is for post-menopausal women aged 18 or older with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Participants must not have had systemic therapy, statins, or certain cholesterol medications in the last 3 months and should have no active liver disease. They need normal blood counts and organ function tests.Check my eligibility

What is being tested?

The study is testing if combining Letrozole with Simvastatin improves treatment outcomes compared to using Letrozole alone in stopping tumor growth. It's an early phase I trial where one group receives both drugs while another only gets Letrozole.See study design

What are the potential side effects?

Possible side effects include muscle pain, fatigue, nausea, increased liver enzymes which could indicate liver damage, and a risk of developing diabetes. Both drugs can also cause digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any active liver disease.

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I am 18 years old or older.

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I am a woman who has gone through menopause.

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My breast cancer is hormone receptor positive and HER2 negative.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney function is within the required range.

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My cancer is positive for estrogen or progesterone receptors.

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My cancer is HER2 negative based on specific tests.

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I have had both of my ovaries surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean percentage change in Ki-67

Secondary outcome measures

Regulatory T-Lymphocytes

Incidence of adverse events

Patient-Reported Outcomes Measurement Information System (PROMIS) for pain

+1 more

Other outcome measures

Changes in HMG-CoA reductase immunohistochemistry (IHC) expression in the tumor tissue

Interleukin-6

Body Weight Changes

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (letrozole, simvastatin)Experimental Treatment2 Interventions

Patients receive letrozole PO QD and simvastatin PO QD for 14 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (letrozole)Active Control1 Intervention

Patients receive letrozole PO QD for 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simvastatin

2012

Completed Phase 4

~1270

Letrozole

2002

Completed Phase 4

~3240

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,534 Total Patients Enrolled

28 Trials studying Breast Cancer

3,028 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,602 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Ruth L SacksPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05464810 — Phase < 1

Breast Cancer Research Study Groups: Arm I (letrozole, simvastatin), Arm II (letrozole)

Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT05464810 — Phase < 1

Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464810 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant pool for this research study?

"Confirmed. According to clinicaltrials.gov, this trial was first published on September 2nd 2022 and has been actively seeking participants ever since; the most recent update being November 21st 2022. Altogether, 40 subjects are needed between 3 sites for data collection purposes."

Answered by AI

Is enrollment presently open for this research study?

"That is correct. The information shared on clinicaltrials.gov affirms that this research project, which was initially published on September 2nd 2022, is actively enrolling patients. A total of 40 participants are to be recruited from 3 distinct medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ruth Sacks 2022. "Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05464810.