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Aromatase Inhibitor

Exemestane + Entinostat for Advanced Breast Cancer

Phase 3
Waitlist Available
Led By Roisin M Connolly
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible
Patients must not have known central nervous system metastasis or a history of central nervous system (CNS) metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is studying the combination of exemestane and entinostat to treat patients with hormone receptor-positive breast cancer.

Who is the study for?
This trial is for adults with hormone receptor-positive breast cancer that's advanced or spread, who can swallow pills and have no known allergies to the drugs being tested. They should not be pregnant, breastfeeding, or have certain medical conditions that could affect participation. Only one prior chemo regimen for metastatic disease is allowed.Check my eligibility
What is being tested?
The study compares exemestane alone versus exemestane with entinostat in treating advanced breast cancer. Exemestane lowers estrogen to fight cancer; entinostat blocks enzymes needed by tumor cells to grow. The effectiveness of combining these treatments is being evaluated.See study design
What are the potential side effects?
Possible side effects include digestive issues, fatigue, blood disorders from exemestane; plus additional risks like inflammation and possible organ damage from entinostat due to enzyme inhibition affecting cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is advanced and cannot be cured with surgery or radiation.
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I do not have, nor have I ever had, cancer spread to my brain.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is positive for estrogen or progesterone receptors.
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I finished my radiotherapy at least 2 weeks ago and have recovered from its side effects.
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I can swallow pills.
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I am not currently on any cancer treatments not listed in the study.
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I am not currently taking valproic acid or any HDAC inhibitors, nor have I taken them before.
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I am not allergic to exemestane, entinostat, or similar medications.
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My cancer does not have high levels of HER2 according to tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS)
Secondary outcome measures
Lysine Acetylation Change in CD45 Blood Mononuclear Cells Between C1D1 and C1D15 and PFS in Patients on Arm A
Objective Response Rate (ORR)
Patient-reported Diarrhea
+4 more
Other outcome measures
Adherence to study
Overall health-related quality of life (HRQL) score
Percent change in protein lysine acetylation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (exemestane, entinostat)Experimental Treatment8 Interventions
Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline. Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.
Group II: Arm B (exemestane, placebo)Placebo Group8 Interventions
Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline. Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Goserelin
2008
Completed Phase 3
~7100
Entinostat
2017
Completed Phase 2
~1170
Exemestane
2003
Completed Phase 4
~7880
Goserelin Acetate
2007
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,545 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Roisin M ConnollyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

Exemestane (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02115282 — Phase 3
Breast Cancer Research Study Groups: Arm B (exemestane, placebo), Arm A (exemestane, entinostat)
Breast Cancer Clinical Trial 2023: Exemestane Highlights & Side Effects. Trial Name: NCT02115282 — Phase 3
Exemestane (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02115282 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI
~55 spots leftby Apr 2025