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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2020-05-05
NCT02115282Uploaded 11-30-2023
Access via NCI by Request
PDS UID: nci-data-529
A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced Breast Cancer
Provider Information
Provider Data DescriptionThere are two submissions for PMID 34357781. This dataset, NCT02115282-D1, contains baseline, treatment, and efficacy data. Dataset NCT02115282-D2 contains toxicity data.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAnatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Breast Adenocarcinoma
HER2/Neu Negative
Locally Advanced Breast Carcinoma
Metastatic Breast Carcinoma
Recurrent Breast Carcinoma
Intervention TypeProcedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Entinostat
Drug: Exemestane
Drug: Goserelin
Drug: Goserelin Acetate
Procedure: Magnetic Resonance Imaging
Other: Placebo Administration
Other: Quality-of-Life Assessment
Drug(s)Drug: Entinostat
Drug: Exemestane
Drug: Goserelin
Drug: Goserelin Acetate
Total Enrolled608
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm A (exemestane, entinostat) - Experimental
Arm B (exemestane, placebo) - Placebo Comparator
Secondary IDNCI-2014-00746
PubMed (PMID)34357781
Collaborator(s)N/A
Region(s)United States
South Africa
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT02115282-D1
Data DictionaryNCT02115282-D1-Data-Dictionary_1.pdf
DATANCT02115282-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT02115282-D2
Data DictionaryNCT02115282-D2-Data-Dictionary.pdf
DATANCT02115282-D2-Dataset.csv
OTHERREADME.pdf
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