NCTN: A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer (E2112)

Study ID: E2112

NCT Number: NCT02115282

ECOG-ACRIN Cancer Research Group

Submitted in collaboration with the NCTN/NCORP Data Archive

Trial Title: NCTN: A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer (E2112)

Trial Description: 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.

Clinical data presented in the following publication(s):

• PMID 34357781

Disease type(s):

• Breast Neoplasm - Breast Cancer - Invasive
• Breast Neoplasm - Breast Neoplasm, Miscellaneous

Clinical dataset(s) included:

• NCT02115282-D1 (PMID 34357781): There are two datasets for PMID 34357781. This dataset, NCT02115282-D1, contains baseline characteristics, stratification factors, ER and PgR status, treatment, lysine acetylation, grade 5 toxicity, and efficacy data.
• NCT02115282-D2 (PMID 34357781): There are two datasets for PMID 34357781. This dataset, NCT02115282-D2, contains toxicity data.

You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

• Type: Double-Blind
• Archive: The database of Genotypes and Phenotypes (dbGaP)