NCT00553410 · OUTCOME

Overall Survival

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer · Source last updated 2026-09-01

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

Measure: NUMBER
Unit: percentage of patients
Interval / dispersion: 95% Confidence Interval
Time frame: 5-year estimates, reported at a median follow-up of 60 months

What was measured

Duration of time from randomization to death from any cause, or was censored at the date last known alive. (Note, for patients who withdrew consent or were lost to follow-up but follow-up for survival was possible through hospital or registry records, OS was censored at the date last known alive rather than date of last follow-up/withdrawn consent).

Analysis population: Intention-to-treat

Groups in this outcome

Arm A: Continuous Letrozole

Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously

Arm B: Intermittent Letrozole

Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months

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
Arm A: Continuous Letrozole	2426
Arm B: Intermittent Letrozole	2425

Reported measurements

Source class 1

Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Continuous Letrozole	93.7	Not reported	92.6	94.7	Not reported
Arm B: Intermittent Letrozole	94.3	Not reported	93.2	95.2	Not reported

Source statistical analyses

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

ci Lower Limit
.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
.16
param Type
Hazard Ratio (HR)
param Value
.85
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
.16
param Type
Hazard Ratio (HR)
param Value
.85
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
92.6
upper Limit
94.7
value
93.7
group Id
OG001
lower Limit
93.2
upper Limit
95.2
value
94.3

denoms

counts
group Id
OG000
value
2426
group Id
OG001
value
2425
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
id
OG000
title
Arm A: Continuous Letrozole
description
Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
id
OG001
title
Arm B: Intermittent Letrozole

param Type

NUMBER

population Description

Intention-to-treat

reporting Status

POSTED

time Frame

5-year estimates, reported at a median follow-up of 60 months

title

Overall Survival

type

SECONDARY

unit Of Measure

percentage of patients

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

Preserved source evidence · Not medical advice