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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
Be older than 18 years old
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.
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
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 moreOther 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 • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
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
~2770
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,645 Previous Clinical Trials
2,564,510 Total Patients Enrolled
28 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,324 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Ruth L SacksPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unmanaged ongoing illnesses.I do not have any active liver disease.I am 18 years old or older.I am a woman who has gone through menopause.My kidney function is within the required range.My cancer is HER2 negative based on specific tests.I have had both of my ovaries surgically removed.I am not taking strong CYP3A4 inhibitors, cyclosporine, danazol, or gemfibrozil.I haven't taken part in any other clinical trials within the last 3 months.I haven't taken statins, fibrates, or ezetimibe in the last 3 months.I haven't had any systemic therapy in the last 3 months.My breast cancer is hormone receptor positive and HER2 negative.My cancer is positive for estrogen or progesterone receptors.I have had serious heart problems in the last 3 months.I can take care of myself and am up and about more than half of my waking hours.I have another cancer that is getting worse or needs treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (letrozole, simvastatin)
- Group 2: Arm II (letrozole)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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