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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
No Placebo-Only Group
Summary
This trial tests if adding simvastatin to letrozole is better at stopping cancer cell growth in postmenopausal women with specific types of breast cancer. Letrozole lowers estrogen levels, and simvastatin may block enzymes that help cancer cells grow.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean percentage change in Ki-67
Secondary study objectives
Regulatory T-Lymphocytes
Incidence of adverse events
Response per Ki-67
Other study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~3590
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Aromatase inhibitors like Letrozole reduce estrogen levels by inhibiting the enzyme aromatase, which converts androgens into estrogens. This is particularly effective for estrogen receptor-positive breast cancer, as estrogen promotes cancer cell growth.
Simvastatin, a statin, may block enzymes involved in cell growth, potentially enhancing Letrozole's effects. Understanding these mechanisms helps tailor treatments to target specific cancer pathways, improving outcomes and minimizing side effects for breast cancer patients.
KRAS-Mutated, Estrogen Receptor-Positive Low-Grade Serous Ovarian Cancer: Unraveling an Exceptional Response Mystery.Femara and the future: tailoring treatment and combination therapies with Femara.Importance of correlative science in advancing hormonal therapy and a new clinical paradigm for neoadjuvant therapy.
KRAS-Mutated, Estrogen Receptor-Positive Low-Grade Serous Ovarian Cancer: Unraveling an Exceptional Response Mystery.Femara and the future: tailoring treatment and combination therapies with Femara.Importance of correlative science in advancing hormonal therapy and a new clinical paradigm for neoadjuvant therapy.
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,651 Total Patients Enrolled
28 Trials studying Breast Cancer
7,454 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,104 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,255 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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