Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
Status:
Terminated
Trial end date:
2019-10-11
Target enrollment:
Participant gender:
Summary
This study is investigational and is not designed to treat cancer. In other words, the study
drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at
the effects of entinostat on tumor tissue for research purposes only.
Approximately 246,660 cases of breast cancer were diagnosed in the United States in 2016. Its
detection and treatment remains a major concern in women's healthcare. In particular, TNBC
accounts for approximately 15-20% of all breast cancers. Research into treatment for breast
cancer relies more and more on understanding how the cancer cells act when they are exposed
to an anti-cancer drug. How most cancer cells act when exposed to anti-cancer drugs and which
patients as a result may benefit the most from these drugs is not well known. Additional
studies are required to determine the cells' reactions. The purpose of part 1 of this study
is to better understand how TNBC tumors react to one particular cancer drug, entinostat.
Entinostat is currently being studied across multiple clinical trials for the treatment of
breast cancer, other solid tumors and blood cancers. Entinostat is investigational and has
not yet been FDA approved for the treatment of cancer.
Studies have shown that a good way to determine how cancer acts when exposed to anti-cancer
drugs is a short-term preoperative window study. In this type of study, subjects receive a
study drug a couple of days before surgery. Leftover tissue from surgery is then used to
determine some of the effects that a study drug may have on the tumor. In this study,
subjects will receive two doses of entinostat prior to undergoing planned surgery. Leftover
tissue from this surgery will then be used to determine the effects entinostat has on tumor
cells. For example, the study team will examine if the types of genes and proteins that the
tumor expresses as a result of entinostat exposure increases or decreases the likelihood that
the tumor will not continue to grow. A gene is a unit of DNA. Genes make up the chemical
structure carrying your genetic information that may determine human characteristics (i.e.,
eye color, height and sex). This study will focus on discovering how entinostat affects a
wide variety of genes in tumor cells.
Phase:
Early Phase 1
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborators:
National Cancer Institute (NCI) Syndax Pharmaceuticals