NCT00005957 · OUTCOME

Disease-free 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 disease-free at 10 years
Interval / dispersion: 95% Confidence Interval
Time frame: 10 years

What was measured

Disease-free survival (including locoregional and distant disease)

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

Group	Source count
Standard Breast Irradiation	916
Breast Radiation Plus Regional Radiation	916

Reported measurements

Source class 1

Values in percentage of disease-free at 10 years · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard Breast Irradiation	77	Not reported	74	80	Not reported
Breast Radiation Plus Regional Radiation	82	Not reported	79	85	Not reported

Source statistical analyses

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

ci Lower Limit
0.61
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.01
param Type
Hazard Ratio (HR)
param Value
0.76
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.61
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.01
param Type
Hazard Ratio (HR)
param Value
0.76
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
74
upper Limit
80
value
77
group Id
OG001
lower Limit
79
upper Limit
85
value
82

denoms

counts
group Id
OG000
value
916
group Id
OG001
value
916
units
Participants

description

Disease-free survival (including locoregional and distant disease)

dispersion Type

95% Confidence Interval

groups

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
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

Disease-free Survival

type

SECONDARY

unit Of Measure

percentage of disease-free at 10 years

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

Preserved source evidence · Not medical advice