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Comparison · NCT02115282-deaths

Arm A (Exemestance, Entinostat) vs Arm A (Exemestance, Placebo): deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Arm A (Exemestance, Entinostat) vs Arm A (Exemestance, Placebo): deaths from any cause. Trial comparisons, record NCT02115282-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02115282-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6850.6310.735wilson
Risk in group 20.670.6150.72wilson
Risk difference, group 1 minus group 20.0153-0.05880.0891newcombe hybrid score
Risk ratio, group 1 over group 21.020.9171.14log
Odds ratio, group 1 over group 21.070.7631.51log
Number needed to harm, for one more death from any cause on Arm A (Exemestance, Entinostat) than on Arm A (Exemestance, Placebo)65.4from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm A (Exemestance, Entinostat)
Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Entinostat: Given PO~Exemestane: Given PO~Goserelin Acetate: Given SC
209305EG000
Group 2Arm A (Exemestance, Placebo)
Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.~Exemestane: Given PO~Goserelin Acetate: Given SC~Placebo Administration: Given PO
203303EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Assessed every cycle (1 cycle=28 days) while on treatment and for 30 days after the end of treatment, up to 10 years from study entry

Source ClinicalTrials.gov

Trial

Title
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
NCT number
NCT02115282
Phases
PHASE3
Conditions
Anatomic 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
Interventions
Biospecimen Collection, Computed Tomography, Entinostat, Exemestane, Goserelin, Goserelin Acetate, Magnetic Resonance Imaging, Placebo Administration, Quality-of-Life Assessment
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2021-11-16

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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