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

第3相実施中（募集終了） NCT02115282

対象疾患	Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative
相	第3相
スポンサー	National Cancer Institute (NCI)
ステータス	実施中（募集終了）
参加者数	608 名
介入（薬剤）	Biospecimen Collection, Computed Tomography, Entinostat, Exemestane, Goserelin
開始日	2014年3月29日
完了日	2020年5月5日
結果公開日	2021年11月16日

概要

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-value	0.30
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-value	0.94
Hazard Ratio (HR)	0.99 (95% CI 0.82–1.21)

BENITIONS で見る ClinicalTrials.gov の原文を見る

同じ疾患の他の治験

Vitamin D and Physical Activity on Bone Health — University of Rochester
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in T — National Cancer Institute (NCI)
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced — National Cancer Institute (NCI)
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Can — AstraZeneca
Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Adm — University of Colorado, Denver
Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer — National Cancer Institute (NCI)

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。

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