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HMG-CoA Reductase Inhibitor

Simvastatin for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Michael Simon

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 baseline up to 4 weeks

Awards & highlights

Study Summary

This trial is testing whether simvastatin can stop the growth of breast cancer cells and reduce the aggressiveness of the cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Ki-67 Expression Assessed in Tumor Tissue by Immunohistochemistry

Other outcome measures

C-reactive Protein (CRP) as a Marker of Inflammation

Change in (% Intracellular p27 +) From Pre-treatment to Post-treatment

Change in Percentage of Cells P27+ From Pre-treatment to Post-treatment

+3 more

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041

11%

Myalgia

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin D and Placebo

Simvastatin and Placebo

Simvastatin and Vitamin D

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (simvastatin)Experimental Treatment2 Interventions

Patients receive simvastatin PO daily for 2-4 weeks 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michael SimonLead Sponsor

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,643 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Could you provide information on the safety of Simvastatin usage?

"Our staff at Power rated Simvastatin's safety a 2, as there is evidence of its security but no proof that it works."

Answered by AI

Have any other investigations been conducted on the efficacy of Simvastatin?

"At present, 37 clinical trials which focus on Simvastatin are underway. Of those studies, 7 have reached Phase 3 status. Pontyclun in Wales serves as a hub for these investigations; however, there are 480 sites globally that support research into the drug's efficacy and safety profile."

Answered by AI

Are there any vacancies for individuals wishing to participate in this experiment?

"The recruitment period for this research is now closed. It was first posted on March 9th 2018 and last updated June 17th 2022. If you are seeking alternative studies, 2282 clinical trials that address invasive breast carcinoma are currently recruiting individuals while 37 experiments regarding Simvastatin require participants as well."

Answered by AI

What pathologies are typically remedied through Simvastatin usage?

"Simvastatin is a medication most commonly administered to reduce cholesterol levels. It can also be taken as an effective treatment for diabetes mellitus, prophylaxis of cardiovascular events and hypercholesterolemia."

Answered by AI

How many participants are currently enrolled in this medical research?

"This research is not currently recruiting participants. It was initially announced on March 9th, 2018 and has most recently been updated June 17th 2022. If the patient desires to explore other studies, there are presently 2282 clinical trials actively enrolling patients with invasive breast carcinoma and 37 trials for Simvastatin recruiting subjects."

Answered by AI

Is this trial a pioneering effort in its field?

"Presently, the worldwide clinical trial landscape for Simvastatin includes 37 active studies that are being conducted in 239 cities and 31 countries. Merck Sharp & Dohme LLC first tested this medication back in 2005, recruiting 80 patients to complete Phase 4 drug approval; since then 873 trials have concluded."

Answered by AI

Recent research and studies

Anti-Cancer DrugsJournal

Simvastatin Enhances the Efficacy of Nilotinib in Chronic Myeloid Leukaemia by Post-translational Modification and Drug Transporter Modulation

Asari, Kartini, Wen Tian Sun, Ze Hui Kok, Yi Hui Lam, Bee Ling Ng, Verity Saunders, Deborah L. White, Charles Chuah, and Wei Xiang. 2021. “Simvastatin Enhances the Efficacy of Nilotinib in Chronic Myeloid Leukaemia by Post-translational Modification and Drug Transporter Modulation”. Anti-cancer Drugs. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cad.0000000000001028.

clinicaltrials.govStudy

The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer

Michael Simon 2018. "The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03454529.