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Study Summary
This trial will test if a new medication, enzalutamide, is safe and effective for treating patients with advanced breast cancer who express the androgen receptor, but not the estrogen or progesterone receptor, and are not Her2 amplified.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 215 Patients • NCT02116582Trial Design
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- You have a stomach or intestine problem that makes it hard for your body to absorb medicine.You had another type of cancer within the last 5 years.You had radiation therapy within 7 days before the study starts.You have a history of seizures or any condition that makes you more likely to have a seizure.You need to have a sample of your tumor for testing, and it needs to show either measurable disease or nonmeasurable disease in the bones.You had a low blood sugar episode that needed medical help while taking insulin in the last year.You have advanced triple-negative breast cancer that is positive for androgen receptors.You are currently using hormone replacement therapy.Women who are 18 years old or olderYour blood counts are too low, including white blood cells, platelets, or hemoglobin.You have or had cancer that has spread to your brain.You have a serious heart condition.You are allergic to the main ingredient or any parts of the capsules, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.Your creatinine level is higher than it should be during the screening visit.If you have a serious health problem or infection, you cannot participate.You are able to perform daily activities without restrictions or with only slight restrictions.
- Group 1: Enzalutamide
- 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
What is the scientific research history of Enzalutamide?
"103 clinical trials are currently underway to further investigate Enzalutamide. 30 of these studies have reached Phase 3. Most of the research being conducted for Enzalutamide is based in Germantown, Tennessee; however, there are 5748 locations running clinical trials for this medication."
What is the goal of this clinical trial?
"The main objective of this study is to assess the clinical benefit of the treatment at Week 16. This will be measured in the Intent-to-Treat population. Secondary objectives include assessing the clinical benefit at Week 24 in the Evaluable Population, which is defined as those who show a response of CR, PR, or SD for >= 24 weeks on radiologic imaging. The team plans to use the Blaker method to calculate an estimate of the percentage and its exact 2-sided 85% CI. Additionally, they will measure Progression-Free Survival in the ITT population, defined as time (in weeks) from first dose"
In how many hospitals is this research project being conducted?
"Patients can enrol in this study at 82 different locations, with three of those sites being Tennessee Oncology, PLLC in Nashville, Tennessee; Florida Cancer Specialists in Venice, Florida; and The Sarah Cannon Research Institute in Lone Tree, Colorado."
How many people are being accepted into this trial?
"Currently, this study is not enrolling patients. The listing for this trial was first created on June 12th, 2013 and was last updated on May 20th, 2022. However, there are 2440 other trials recruiting patients with triple negative breast neoplasms and 103 trials for Enzalutamide admitting patients at this time."
Could you please provide more information on the risks associated with Enzalutamide?
"Enzalutamide's efficacy is unproven, however it did receive a score of 2 due to prior clinical data supporting its safety."
Are patients currently being enrolled in this trial?
"Unfortunately, this specific study is not looking for new patients at the moment. It was originally posted on June 12th, 2013 but was most recently edited on May 20th, 2022. There are 2543 other trials that ARE currently recruiting participants however."
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