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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

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Progression-free Survival (PFS)

Secondary study objectives

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 study objectives

Adherence to study

Overall health-related quality of life (HRQL) score

Percent change in protein lysine acetylation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180