Azacitidine + Entinostat for Advanced Breast Cancer

Recruiting at6 trial locations

Overseen by Vered Stearns

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Vered Stearns

Principal Investigator

Johns Hopkins University/Sidney Kimmel Cancer Center

Eligibility Criteria

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.

Treatment Details

Interventions

• Azacitidine (Anti-metabolites)
• Entinostat (Histone Deacetylase Inhibitor)

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.

Participant Groups

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 Canada, Japan for the following indications:

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+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School