Conditions: Breast Cancer Estrogen Receptor-Positive Breast Cancer Breast Cancer, Estrogen Receptor-Positive ER+ Breast Cancer
Keywords: Breast Neoplasms Breast Tumor Mammary Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.

Detailed description:

Arms:
arm 1: Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first. arm 2: Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.

Interventions: intervention 1: entinostat intervention 2: exemestane intervention 3: Placebo
Intervention descriptions: intervention 1: Entinostat 5 mg tablet orally once per week intervention 2: Exemestane 25 mg tablet orally once daily intervention 3: Placebo-matching entinostat tablet orally once per week

Protocol document: