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

Phase 3 Active, not recruiting NCT02115282

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.

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

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

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

• 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)

All trials