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Anti-metabolites

Azacitidine + Entinostat for Advanced Breast Cancer

Phase 2

Waitlist Available

Led By Vered Stearns

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

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast triple-negative (ER-, progesterone receptor [PR]-, human epidermal growth factor receptor 2 [HER2]-) or hormone positive/ HER2-, with evidence of locally advanced and inoperable or metastatic disease (American Joint Committee on Cancer [AJCC] Stage IV)

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Must not have

Uncontrolled intercurrent illness that in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens including, but not limited to: Ongoing or active infection, Symptomatic congestive heart failure (New York Heart Association [NYHA] class II or above), Unstable angina pectoris, Cardiac arrhythmia, Psychiatric illness/social situations that would limit compliance with study requirements, Other co-morbid systemic illness or other severe concurrent disease, Active malignancy other than breast cancer =< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer, Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, Received prior treatment with HDAC (histone deacetylase) inhibitors or demethylating agents =< 2 weeks prior to registration, Unstable brain metastases; NOTE: patients with brain metastases must have stable neurologic status and magnetic resonance imaging (MRI) imaging following local therapy (surgery or radiation) for at least 4 weeks, with no dexamethasone requirement (stable low dose dexamethasone allowed at discretion of Study Chair); patients with leptomeningeal disease are not eligible, Patient taking valproic acid, Patient who cannot swallow tablets

Bevacizumab < 6 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of drugs to treat patients with advanced breast cancer.

Who is the study for?

This trial is for adults with advanced breast cancer that's either triple-negative or hormone-positive/HER2-. They must have tried certain treatments already and be in good enough health to participate. Patients need to provide tissue and blood samples, not be pregnant, use contraception if they can have children, and agree to follow-up visits.

What is being tested?

The study tests azacitidine combined with entinostat on patients with advanced breast cancer. Azacitidine is a chemotherapy drug that kills or stops tumor cells from dividing. Entinostat blocks enzymes needed for cell growth. The hope is this combination will kill more tumor cells.

What are the potential side effects?

Possible side effects include reactions related to the immune system, fatigue, nausea, vomiting, low blood counts leading to increased infection risk or bleeding problems. Specific side effects of each drug may vary and should be discussed with the healthcare team.

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, cannot be removed by surgery, and is either triple-negative or hormone positive/HER2-.

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I am fully active or can carry out light work.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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Less than 30% of my liver is affected by cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any severe illnesses that would affect my participation in the study.

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I have not taken Bevacizumab in the last 6 weeks.

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I haven't had chemotherapy in the last 3 weeks.

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I am allergic to 5-AZA, entinostat, or mannitol.

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I have not had surgery in the last 3 weeks.

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I am of childbearing age and do not plan to use birth control.

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I have not taken nitrosoureas or mitomycin C in the last 6 weeks.

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I haven't taken Trastuzumab in the last 6 weeks.

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I am currently breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Confirmed Response Rate (Percentage of Participants With Complete or Partial Response Noted as the Objective Status on Two Consecutive Evaluations at Least 4 Weeks Apart) Assessed by RECIST

Secondary study objectives

Clinical Benefit Rate

Overall Survival

Progression-free Survival (PFS)

Other study objectives

Circulating DNA Evaluated Using QM-MSP

Confirmed Response Rate to Azacitidine and Entinostat Plus the Addition of Hormone Therapy

Number of Participants With Change in Expression of Relevant Genes (e.g., ER Alpha and RAR Beta) Evaluated by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (entinostat and azacitidine)Experimental Treatment4 Interventions

Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Entinostat

2017

Completed Phase 2

~1320