NCT00075764 · OUTCOME

Overall Survival

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer · Source last updated 2021-01-13

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.

What was measured

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.

Groups in this outcome

Arm I Anastrozole

Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally

Arm II Anastrozole and Fulvestrant

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly

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 I Anastrozole	345
Arm II Anastrozole and Fulvestrant	349

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm I Anastrozole	41.3	Not reported	37.2	45.0	Not reported
Arm II Anastrozole and Fulvestrant	47.7	Not reported	43.4	55.7	Not reported

Source statistical analyses

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

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.00
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.049
param Type
Hazard Ratio (HR)
param Value
0.81
statistical Comment
A log-rank test, stratified according to prior or no prior tamoxifen therapy.
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.00
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.049
param Type
Hazard Ratio (HR)
param Value
0.81
statistical Comment
A log-rank test, stratified according to prior or no prior tamoxifen therapy.
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
37.2
upper Limit
45.0
value
41.3
group Id
OG001
lower Limit
43.4
upper Limit
55.7
value
47.7

denoms

counts
group Id
OG000
value
345
group Id
OG001
value
349
units
Participants

description

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.

dispersion Type

95% Confidence Interval

groups

description
Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally
id
OG000
title
Arm I Anastrozole
description
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly
id
OG001
title
Arm II Anastrozole and Fulvestrant

param Type

MEDIAN

reporting Status

POSTED

time Frame

Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.

title

Overall Survival

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice