E2112 A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The purpose of this study is find out what effects, both good and bad, an experimental drug called entinostat has on you and your cancer, when given together with the standard hormonal drug treatment, exemestane.
People with breast cancer that cannot be removed by surgery (locally advanced) or has spread (metastasized) to another part of your body may be eligibile to participate in this study. The following are additional requirements: * Generally healthy adult men or postmenopausal women, * ER and/or PR positive breast cancer, * HER2 negative tumor, * No CNS involvement, * Disease-free for more than 5 years of other cancer(s), * Progressed or relapsed after receiving aromotase inhibitor therapy, * May have received one (1) prior chemotherapy regimen more than 3 weeks ago, * May have received radiation therapy more than 2 weeks ago, and * Normal laboratory blood results.
Consented and eligible subjects will receive exemestane by mouth daily. Subjects will also take etinostat or a matching placebo by mouth once a week. The subject , study nurse and study doctor will not know if the subject is taking etinostat or the matching placebo. Subjects will be asked to come in to see their study doctor once a month and return for imaging tests every 3 months. All subjects will continue to take these study drugs until they can no longer tolerate it or their disease worsens. All subjects will be followed for survival for up to 10 years after they join the study.
06/24/2016 05:01 AM