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NCT00005957 · OUTCOME

Overall Survival

Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer · Source last updated 2023-08-21

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

Measure
NUMBER
Unit
percentage of alive at 10 years
Interval / dispersion
95% Confidence Interval
Time frame
10 years

What was measured

Duration of study

Analysis population: Intention-to-treat

Groups in this outcome

Standard Breast Irradiation

radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.

Breast Radiation Plus Regional Radiation

regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.

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

Analysis denominator · Participants

GroupSource count
Standard Breast Irradiation916
Breast Radiation Plus Regional Radiation916

Reported measurements

Source class 1
Values in percentage of alive at 10 years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard Breast Irradiation82Not reported7984Not reported
Breast Radiation Plus Regional Radiation83Not reported8085Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.13
    estimate Comment
    Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.
    group Description
    It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.38
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.13
    estimate Comment
    Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.
    group Description
    It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.38
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        79
        upper Limit
        84
        value
        82
      2. group Id
        OG001
        lower Limit
        80
        upper Limit
        85
        value
        83
denoms
  1. counts
    1. group Id
      OG000
      value
      916
    2. group Id
      OG001
      value
      916
    units
    Participants
description
Duration of study
dispersion Type
95% Confidence Interval
groups
  1. description
    radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
    id
    OG000
    title
    Standard Breast Irradiation
  2. description
    regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
    id
    OG001
    title
    Breast Radiation Plus Regional Radiation
param Type
NUMBER
population Description
Intention-to-treat
reporting Status
POSTED
time Frame
10 years
title
Overall Survival
type
PRIMARY
unit Of Measure
percentage of alive at 10 years

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

Preserved source evidence · Not medical advice