← Back to Search

Simvastatin + Anti-HER2 Therapy for Breast Cancer (SIMPHONY Trial)

Phase 2
Waitlist Available
Led By Mothaffar Rimawi, MD
Research Sponsored by Baylor Breast Care Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Concomitant endocrine therapy is acceptable and may be continued at the discretion of the treating physician
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

SIMPHONY Trial Summary

This trial is testing whether adding simvastatin to a dual anti-HER2 therapy regimen can help make tumors respond to the anti-HER2 therapy again in patients with metastatic breast cancer.

Who is the study for?
This trial is for women aged 18+ with metastatic breast cancer that's HER2-positive and has progressed despite anti-HER2 therapy. They must have measurable disease, adequate organ function, controlled CNS metastases if present, and a life expectancy of at least 12 weeks. Exclusions include recent statin use, hypersensitivity to statins, severe diseases, certain infections like HIV/HBV/HCV, other recent cancers except some skin cancers or cervical carcinoma in situ.Check my eligibility
What is being tested?
The study tests the effectiveness of adding simvastatin (80mg) to existing dual anti-HER2 therapy in patients whose tumors no longer respond to this treatment. All participants will continue their current anti-HER2 regimen plus the added simvastatin.See study design
What are the potential side effects?
Potential side effects from simvastatin may include muscle pain or weakness (rarely leading to serious conditions like rhabdomyolysis), liver problems (indicated by abnormal blood tests), digestive issues such as nausea or constipation, headache, and increased risk of diabetes.

SIMPHONY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on hormone therapy for my condition, and my doctor can decide if it continues.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have not had chemotherapy in the last month.
Select...
I haven't had major surgery or radiation therapy in the last 28 days.
Select...
You must have normal levels of certain blood cells, kidney function, liver function, and heart function. If you have cancer in the brain, it must be stable for at least 3 months. If you can get pregnant, you need to have a negative pregnancy test and agree to use birth control during the study.
Select...
My ER+/HER2+ cancer progressed despite dual anti-HER2 and hormone therapy.
Select...
I am a woman and I am 18 years old or older.
Select...
My breast cancer worsened despite receiving two HER2-targeted treatments.
Select...
My breast cancer has spread and cannot be cured with surgery or radiation.
Select...
My ER-/HER2+ cancer did not respond to at least one chemotherapy treatment.
Select...
My cancer is HER2-positive as per specific guidelines.
Select...
I can take pills by mouth.

SIMPHONY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response
Secondary outcome measures
Clinical benefit
Duration of Response
HMG-CoA Reductase and HMG-CoA Synthase 1 protein levels in baseline and post-treatment tumor biopsies
+2 more

SIMPHONY Trial Design

1Treatment groups
Experimental Treatment
Group I: SimvastatinExperimental Treatment1 Intervention
Simvastatin 80 mg in combination with anti-HER2 therapy regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin 80mg
2007
Completed Phase 4
~140

Find a Location

Who is running the clinical trial?

Baylor Breast Care CenterLead Sponsor
15 Previous Clinical Trials
748 Total Patients Enrolled
12 Trials studying Breast Cancer
686 Patients Enrolled for Breast Cancer
Mothaffar Rimawi, MD2.610 ReviewsPrincipal Investigator - Baylor College of Medicine
Baylor Breast Care Center
14 Previous Clinical Trials
932 Total Patients Enrolled
11 Trials studying Breast Cancer
834 Patients Enrolled for Breast Cancer
1Patient Review
This doctor is terrible at listening and the office staff and nurses are just as bad. I wouldn't recommend coming here.

Media Library

Simvastatin 80mg Clinical Trial Eligibility Overview. Trial Name: NCT03324425 — Phase 2
Breast Cancer Research Study Groups: Simvastatin
Breast Cancer Clinical Trial 2023: Simvastatin 80mg Highlights & Side Effects. Trial Name: NCT03324425 — Phase 2
Simvastatin 80mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03324425 — Phase 2

Frequently Asked Questions

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

Are there any vacancies left for participants in this experiment?

"The clinical trial is publicly recruiting, with the original listing on March 4th 2020 and a recent amendment published on April 1st 2022. The information can be found online at clinicaltrials.gov"

Answered by AI

What is the uppermost limit of participants in this clinical research endeavor?

"Affirmative. According to information on clinicaltrials.gov, this experiment is currently requesting recruits; it was initially advertised on March 4th 2020 and modified most recently April 1st 2022. The trial requires 34 individuals from two different medical locations to take part in the study."

Answered by AI

Has the FDA sanctioned Simvastatin 80mg for consumer use?

"Our team concluded that Simvastatin 80mgheld a risk factor of 2, as the Phase 2 trial allowed for an estimation of safety but not efficacy."

Answered by AI

Is this an unprecedented research endeavor?

"As of today, 37 clinical trials for Simvastatin 80mg are being conducted across 239 cities and 31 countries. This drug's first trial began in 2005, sponsored by Merck Sharp & Dohme LLC; it involved 80 patients and achieved Phase 4 approval. In the years since then, 298 more studies have been concluded."

Answered by AI

Are there any prior investigations involving Simvastatin 80mg?

"Currently, 37 separate clinical trials are investigating the effects of Simvastatin 80mg with 7 in Phase 3. While some studies for this drug call Pontyclun, Wales home, 480 sites around the world are recruiting patients to be part of these research initiatives."

Answered by AI

What is the typical purpose of a Simvastatin 80mg dosage?

"Simvastatin 80mg is regularly used to manage cholesterol levels, however this medication can also be successful in treating diabetes mellitus, preventing cardiovascular incidents and controlling hypercholesterolemia."

Answered by AI
~3 spots leftby Dec 2028