At a glance
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A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 7 other interventions for Anatomic Stage III Breast Cancer AJCC v8 and 6 related conditions. Active but no longer recruiting, targeting 608 participants across 655 sites in 2 countries.
Detailed Summary
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Study Details
Timeline
Interventions
Undergo collection of blood and archived tissue samples
Undergo CT
Given PO
Given PO
Given PO
Given SC
Undergo MRI
Given PO
Ancillary studies