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NCT00066573 · OUTCOME

Event-free Survival

Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer · Source last updated 2023-08-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
5 years

What was measured

Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.

Groups in this outcome

Exemestane

Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally

Anastrozole

Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Exemestane3789
Anastrozole3787

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Exemestane88Not reported8789Not reported
Anastrozole89Not reported8890Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.85
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.85
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87
        upper Limit
        89
        value
        88
      2. group Id
        OG001
        lower Limit
        88
        upper Limit
        90
        value
        89
denoms
  1. counts
    1. group Id
      OG000
      value
      3789
    2. group Id
      OG001
      value
      3787
    units
    Participants
description
Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally
    id
    OG000
    title
    Exemestane
  2. description
    Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
    id
    OG001
    title
    Anastrozole
param Type
NUMBER
reporting Status
POSTED
time Frame
5 years
title
Event-free Survival
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice