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Exemestane + Entinostat for Advanced Breast Cancer
Study Summary
This trial is studying the combination of exemestane and entinostat to treat patients with hormone receptor-positive 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.Trial Design
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Who is running the clinical trial?
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- My breast cancer is advanced and cannot be cured with surgery or radiation.I do not have, nor have I ever had, cancer spread to my brain.My blood, liver, and kidney functions are all within normal ranges.I am fully active or restricted in physically strenuous activity but can do light work.My breast cancer is positive for estrogen or progesterone receptors.I am taking medication for bone health as per ASCO guidelines.I finished my radiotherapy at least 2 weeks ago and have recovered from its side effects.I can swallow pills.I've had only one chemotherapy for my advanced cancer, completed 3 weeks ago or more.I am not currently on any cancer treatments not listed in the study.My cancer does not have high levels of HER2 according to tests.I am a woman of any menopausal status or a man.My condition has worsened or returned after treatment.I am not currently taking valproic acid or any HDAC inhibitors, nor have I taken them before.I am not allergic to exemestane, entinostat, or similar medications.I have recovered from side effects of previous treatments, except for hair loss.I have been cancer-free for over 5 years, except for certain skin cancers or cervical pre-cancer.
- Group 1: Arm B (exemestane, placebo)
- Group 2: Arm A (exemestane, entinostat)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
To your knowledge, has this research been done before?
"As of now, there are 137 clinical trials involving Entinostat that are ongoing in 1914 cities and 61 countries. The very first trial began way back in 2000 and was completed when it reached Phase 3 drug approval stage in 2006. Since then, 339 more trials have been carried out."
Are there any known risks to taking Entinostat?
"Entinostat's safety is estimated to be a 3. This conclusion comes from the fact that Entinostat is in Phase 3 of clinical trials. Having completed multiple rounds of testing with positive results, there is a significant amount of data supporting both the efficacy and safety of this medication."
Are people currently enrolling in this trial?
"Unfortunately, this particular study is not looking for new patients right now. Although, it's worth noting that the last time this trial was edited was on October 18th, 2021. If you're interested in other studies, there are currently 5536 trials actively recruiting breast cancer patients and 137 clinical trials involving Entinostat that are still open to new participants."
What are the key indications for Entinostat?
"While often used as radiation therapy, Entinostat can also be prescribed to manage palliative care, endometrial thinning, and uterine hemorrhage."
How large is the sample size for this study?
"As of right now, this particular trial is not looking for any more patients. It was originally posted on March 29th, 2014 and has had its information edited as recently as October 18th, 2021. If you are interested in other trials, there are presently 5536 studies actively searching for patients with breast cancer and 137 trials for Entinostat that need participants."
What are the goals that researchers hope to achieve with this clinical trial?
"The primary outcome of this clinical trial, which will be evaluated over a Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression time frame is to Progression-free survival (PFS). Secondary outcomes include Time-to-treatment Deterioration (TTD) which is defined as Time-to-treatment deterioration (TTD) was defined as time from randomization to disease progression or death or worsening of symptoms, whichever occurred first. Disease progression was"
In which areas is this research being conducted?
"Currently, there are one hundred participating centres for this clinical trial. Some of these locations include Minnesota Oncology Hematology PA-Maplewood in Maplewood, Cleveland Clinic Akron General in Akron, and Delaware Radiation Oncology in Delaware."
What are the most recent findings from research using Entinostat?
"Entinostat was first explored in 2000 by Centre de Recherche Clinique du CHUS. As of now, 339 clinical trials have been completed while 137 are ongoing. The majority of active studies are taking place in Maplewood, Minnesota."
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