Azacitidine + Entinostat for Advanced Breast Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Valproic acid

Disqualifiers: Pregnancy, Active infection, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 28 days per cycle

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well giving azacitidine and entinostat work in treating patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.

Who Is on the Research Team?

Vered Stearns

Principal Investigator

Johns Hopkins University/Sidney Kimmel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can have a biopsy taken from my tumor, or I've tried but it was unsuccessful.

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

I am fully active or can carry out light work.

Exclusion Criteria

You are currently taking any other experimental medications.

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

I started hormone therapy less than 3 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive azacitidine subcutaneously on days 1-5 and 8-10, and entinostat orally on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Multiple visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3-6 months for up to 3 years.

Up to 3 years

Follow-up visits every 3-6 months

Extension

Participants with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• Entinostat

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (entinostat and azacitidine) Experimental Treatment 4 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.

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Vidaza for:

• Acute myeloid leukemia
• Chronic myelomonocytic leukemia
• Myelodysplastic syndromes

Approved in United States as Vidaza for:

• Myelodysplastic syndromes
• Chronic myelomonocytic leukemia

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+