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Title:

Phase II Study of Azacitidine and Entinostat (SNDX-275) in Patients with Advanced Breast Cancer

Protocol Number:

J1107

Phase:

Phase II

Physician:

Vered Stearns

Purpose:

The purpose of this study is to find out the effects that taking Azacitidine and Entinostat together has on breast cancer. Azacitidine and Entinostat are new targeted anti-cancer agents. In previous clinical trials, patients with different cancers had a decrease in the size of their tumors when treated with Azacitidine and Entinostat. Azacitidine has been FDA approved in another disease called myelodysplastic syndrome. Using Azacitidine and Entinostat in breast cancer is investigational; however the FDA has given us permission to use the drugs for this study.

Eligibility:

Patients who have failed prior chemotherapy or hormonal treatments for their metastatic breast cancer may be eligible for this trial. Patients must have tumor tissue which can be easily biopsied. Patients must be able to swallow pills. Patients will be required to make frequent trips to the clinic.

Treatment:

Participants will have a series of screening tests to make sure it is safe to join the study. Before beginning study treatment a tumor biopsy for research purposes will be done; this will be repeated about two months after starting treatment. Research blood samples will also be collected prior to starting study and frequently during the first 2 months on study. Information from these biopsies and blood tests will help doctors learn more about using Azacitidine and Entinostat in breast cancer and could help future cancer patients. Azacitidine is given in the clinic by subcutaneous injection (SQ) on Monday through Friday the first week, and then Monday through Wednesday the second week. Entinostat tablets are also given in the clinic on the first and second Wednesdays of each cycle (a 28 day period). Participants will have blood tests and follow up scans to assess response, and may remain on study as long as there are not unacceptable side effects and the cancer is responding.

Population:

Adult

Last Update

05/18/2013 04:02 AM

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