BENITIONSClinical Trial Intelligence

Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

3期 进行中(已停止招募) NCT02115282

适应症Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative
分期3期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数608 人
干预(药物)Biospecimen Collection, Computed Tomography, Entinostat, Exemestane, Goserelin
开始日期2014年3月29日
完成日期2020年5月5日
结果公布日2021年11月16日

摘要

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.

Progression-free Survival (PFS)

Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression · months

Arm A (Exemestane, Entinostat)3.3 months
Arm B (Exemestane, Placebo)3.1 months
p-value0.30
Hazard Ratio (HR)0.87 (95% CI 0.67–1.13)

Overall Survival (OS)

Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death · months

Arm A (Exemestane, Entinostat)23.4 months
Arm B (Exemestane, Placebo)21.7 months
p-value0.94
Hazard Ratio (HR)0.99 (95% CI 0.82–1.21)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

同一适应症的其他试验

全部试验

本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。