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Enzalutamide + Exemestane for Advanced Breast Cancer
Study Summary
This trial will test if a combination of drugs is safe and effective for patients with advanced breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
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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Who is running the clinical trial?
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- You have a sample of your breast tumor preserved in a specific way, with a report from a pathologist.You are currently taking any medication that affects the production of male hormones or targets the male hormone receptor.You have had a seizure before or have a condition that could make you more likely to have a seizure.You currently have a gastrointestinal (stomach and intestine) problem that is not under control.You should be in good enough health to carry out everyday activities or be active for at least half of your waking hours.You have a visible sign of disease that can be measured, such as a tumor that can be seen on a scan. If you have advanced breast cancer and your only visible signs of the disease are in your bones or skin, you can still participate.You have had a bad reaction to exemestane in the past.You have gone through menopause.You have only had one hormone therapy and one chemotherapy treatment for your condition.You currently have or have had cancer spread to your brain.You haven't taken certain medications like estrogen, androgen, or systemic radionuclides in the 14 days before starting the study.You have a serious heart condition.You have advanced breast cancer that tests positive for estrogen and/or progesterone receptors and negative for HER-2.You had another type of cancer within the last 5 years before joining the study.You have taken exemestane for metastatic cancer within the last 28 days. If you took exemestane for a different type of cancer and it came back more than a year after you stopped taking the medication, you are eligible.
- Group 1: Placebo & exemestane
- Group 2: Enzalutamide & exemestane
- 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
Can people with the required qualifications join this trial at this time?
"No, this particular clinical trial is not recruiting at the moment. The most recent update on clinicaltrials.gov was on April 26th, 2022 and it stated that the trial is no longer looking for candidates. Although this may be the case, there are 2,860 other trials that are still recruiting participants."
What are some other Enzalutamide-based clinical trials that have already been completed?
"There are a total of 162 trials registered on clinicaltrials.gov that involve Enzalutamide. 53 of those are currently ongoing, andPhase 3. The primary trial location is Duarte, California; however, there are 13376 different centres whereEnzalutamide studies are being conducted."
What are some common indications for Enzalutamide?
"Enzalutamide can help manage the symptoms of postmenopause, as well as advance directives and castration."
Could you please explain the risks of taking Enzalutamide?
"Enzalutamide is a Phase 2 medication, meaning that while there is some evidence pointing to its safety, there is none yet for efficacy. Our team gives it a score of 2."
How many individuals are chosen to participate in this clinical trial?
"This study has finished recruiting patients. The trial was first posted on December 13th, 2013 and was updated for the last time on April 26th, 20212. However, there are currently 2698 trials actively recruiting patients with breast cancer and 162 trials for Enzalutamide that are looking for participants."
How many hospitals are participating in this research?
"Patients can be enrolled at locations such as ATTN-Research Pharmacist in Englewood, Colorado, University of Colorado Cancer Center - Anschutz Cancer Pavilion in Altamonte Springs, Indiana, and Investigational Drug Services in Aurora, Illinois. In total, there are 79 sites where patients can participate."
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