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Simvastatin + Anti-HER2 Therapy for Breast Cancer (SIMPHONY Trial)
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.
SIMPHONY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSIMPHONY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SIMPHONY Trial Design
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Who is running the clinical trial?
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- I am on hormone therapy for my condition, and my doctor can decide if it continues.I can take care of myself but might not be able to do heavy physical work.You drink more than three alcoholic drinks every day.I have not had chemotherapy in the last month.Patients must have a measurable disease according to specific medical criteria.You are expected to live for at least 12 more weeks.I haven't had major surgery or radiation therapy in the last 28 days.I cannot take pills due to issues with my stomach or intestines.I do not have any severe, uncontrolled diseases right now.I am a woman and I am 18 years old or older.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.I do not have serious heart problems or poorly controlled high blood pressure.I have not taken IV antibiotics for an infection in the last 7 days.I have not had any cancer except for cervical or basal cell carcinoma in the last 2 years.My ER+/HER2+ cancer progressed despite dual anti-HER2 and hormone therapy.I have not taken statin medications in the last 2 months.I have had rhabdomyolysis in the past.My breast cancer worsened despite receiving two HER2-targeted treatments.My breast cancer has spread and cannot be cured with surgery or radiation.My ER-/HER2+ cancer did not respond to at least one chemotherapy treatment.My cancer is HER2-positive as per specific guidelines.I have or had HIV, Hepatitis B, or Hepatitis C.I can take pills by mouth.You are allergic to statins.I do not have cancer only in my bones, or if I do, there is a measurable tumor.
- Group 1: Simvastatin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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"
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."
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."
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."
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."
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."
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