Clinical Trial Details for Study "GCC 0927"

Official Title: A PILOT AND PHASE II STUDY OF ENTINOSTAT AND ANASTROZOLE IN POSTMENOPAUSAL WOMEN WITH OPERABLE TRIPLE NEGATIVE BREAST CANCER TO EVALUATE BIOMARKERS AND SURROGATES FOR RESPONSE
Investigator: Saranya Chumsri, M.D.
Summary: Triple negative breast cancer (TNBC) is a subtype of breast cancer. TNBC tumors do not have estrogen, progesterone or human epidermal growth factor receptor 2 (HER2) receptors. Hence the name triple negative breast cancer". TNBC can be a particularly aggressive tumor, and is more likely to come back than other subtypes of breast cancer after surgery, radiation, and chemotherapy. Preclinical data suggest that entinostat can re-sensitize TNBC to endocrine therapy that is not normally effective in TNBC. The purpose of this study is to determine whether the combination of anastrozole (FDA approved endocrine therapy for breast cancer) and entinostat is safe and effective in slowing down the growth of TNBC.
Disease site: Breast
Disease stage: Postmenopausal Operable Breast Cancer
Condition: Triple Negative Breast Cancer (TNBC)
Intervention: Entinostat & Anastrozole
Phase: II
Study number: GCC 0927
Eligibility*
(inclusion criteria)
    Female greater than or equal to 18 years; Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A); Unresected operable breast cancer that meets the following clinical stages as per the protocol;Evidence of hormone insensitivity (ER and PR negative) of primary tumor tissue; Postmenopausal as defined by the protocol; Ability to understand and the willingness to sign a written informed consent document; Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer-see protocol for additional information; Patients must have adequate organ and marrow function as defined by the protocol
(exclusion criteria)
    Patients may not be receiving any other investigational agents; Prior exposure to other HDAC inhibitors. However, prior valproic acid exposure is allowed providing e 30 days wash-out period; History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to entinostat, benzamide, or anastrozole; Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy; Previous or current systemic malignancy within the past 3 years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skin.
Contact Person
 Nancy Tait, RN 410-328-3546
Jane Lewis, RN 410-328-7856
* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.


Email this Page                                                                     Print this Page

Home Site Map Disclaimer University of Maryland Greenebaum Cancer Center UM School of Medicine UM Medical System UM Medical Center Text: If you would like to make an appointment or talk to someone about our services please call 1-800-888-8823. Physicians can call our dedicated consultation referral service at 1-800-373-4111.