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Enobosarm + Abemaciclib for Breast Cancer (VERU-024 Trial)
VERU-024 Trial Summary
This trial is testing the safety of a new drug, enobosarm, when used with the existing drug Verzenio. The second part of the trial is testing whether the new drug combination is more effective than just Verzenio alone in treating metastatic breast cancer.
VERU-024 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVERU-024 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VERU-024 Trial Design
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Who is running the clinical trial?
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- You have a tube in your bile duct.Your ECG shows abnormal results that could put you at higher risk.You have a history of certain heart conditions.You have had a growing or actively treated cancer in the past 5 years.You have a current, serious infection caused by bacteria, fungus, or virus.You are allergic to enobosarm or abemaciclib.You have already had more than one round of chemotherapy for metastatic breast cancer treatment.You are currently taking certain medications or hormone therapies.Your kidneys do not filter blood well enough, with a clearance of less than 30 mL/min.You are 18 years old or older.You have a moderate to high ability to perform daily activities.You have medical records showing that you have metastatic breast cancer that is estrogen receptor positive and HER2 negative.You have tumors in your brain that are not under control.Your disease can be measured using a specific standard called RECIST 1.1.More than 40% of the nuclei in your cells show a specific staining when tested by a central laboratory.You have already been treated with certain medications and your condition got worse.Your organs are working well.
- Group 1: Enobosarm Combination Group
- Group 2: Control Treatment Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this continent-wide trial happening primarily in North America?
"Presently, this clinical trial is looking for patients from a total of 31 sites. While some of these sites are in cities like Saint Louis, Norfolk and Santa Barbara, others are located in more rural areas. If you enroll in the trial, it may be most convenient for you to choose a site that is nearby to avoid extensive travel."
Is this research project only looking for volunteers above the age of 20?
"This clinical trial is for patients aged 18 to 100. There are 92 similar trials for patients that are younger and 2613 for patients that are older."
For what purpose is the Enobosarm & Abemaciclib Combo most commonly used?
"Enobosarm & Abemaciclib Combo can be used to treat rejection, transplant, kidney, waldenstrom macroglobulinemia, and lung."
Might I be able to enroll in this research program?
"This study is only looking for female patients that have been diagnosed with breast cancer. The age limit for this trial is 18 to 100 years old. Out of the 186 total patients needed, how many do you think the researchers will be able to find?"
What are the risks associated with Enobosarm & Abemaciclib Combo?
"Enobosarm & Abemaciclib Combo is a Phase 3 trial medication, so it has received a score of 3 for safety. This reflects the presence of some data supporting efficacy as well as multiple rounds of data supporting safety."
Are there other examples of Enobosarm & Abemaciclib being studied together?
"The first clinical trial for the Enobosarm & Abemaciclib Combo was at Rebecca and John Moores UCSD Cancer Center in 2003. 590 trials have completed since then. There are presently 343 actively recruiting studies, with many of these trials being performed out of Saint Louis, Missouri."
Is this research open to new participants?
"Correct, the information available on clinicaltrials.gov affirms that this study is actively trying to enrol patients. The study was first posted on April 11th, 2022 and was last updated on October 14th, 2022. The study is looking for 186 patients at 31 sites."
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