NCT00066690 · OUTCOME

Overall Survival

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-08-26

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: 8-year estimates, reported at a median follow-up of 8 years

What was measured

Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.

Analysis population: Intention-to-treat

Groups in this outcome

Tamoxifen

Tamoxifen 20mg orally daily for 5 years Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Tamoxifen: Tamoxifen 20mg orally daily for 5 years

T+OFS

Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Tamoxifen: Tamoxifen 20mg orally daily for 5 years Triptorelin: 3.75 mg by im injection q28 days for 5 years

E+OFS

Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane: Exemestane 25mg orally daily for 5 years plus ovarian function suppression Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Triptorelin: 3.75 mg by im injection q28 days for 5 years

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
Tamoxifen	1018
T+OFS	1015
E+OFS	1014

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Tamoxifen	91.5	Not reported	89.4	93.2	Not reported
T+OFS	93.3	Not reported	91.4	94.8	Not reported
E+OFS	92.1	Not reported	90.0	93.7	Not reported

Source statistical analyses

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

ci Lower Limit
0.48
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
T was the reference group in the estimation of the hazard ratio
group Ids
OG000
OG001
non Inferiority Comment
\[not specified\]
non Inferiority Type
SUPERIORITY
p Value
0.01
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Method
Log Rank
ci Lower Limit
0.62
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.15
estimate Comment
T was the reference group in the estimation of hazard ratio
group Ids
OG000
OG002
non Inferiority Comment
\[not specified\]
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.85

Complete source fields

analyses

ci Lower Limit
0.48
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
T was the reference group in the estimation of the hazard ratio
group Ids
OG000
OG001
non Inferiority Comment
\[not specified\]
non Inferiority Type
SUPERIORITY
p Value
0.01
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Method
Log Rank
ci Lower Limit
0.62
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.15
estimate Comment
T was the reference group in the estimation of hazard ratio
group Ids
OG000
OG002
non Inferiority Comment
\[not specified\]
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.85

classes

categories
measurements
group Id
OG000
lower Limit
89.4
upper Limit
93.2
value
91.5
group Id
OG001
lower Limit
91.4
upper Limit
94.8
value
93.3
group Id
OG002
lower Limit
90.0
upper Limit
93.7
value
92.1

denoms

counts
group Id
OG000
value
1018
group Id
OG001
value
1015
group Id
OG002
value
1014
units
Participants

description

Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.

dispersion Type

95% Confidence Interval

groups

description
Tamoxifen 20mg orally daily for 5 years Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Tamoxifen: Tamoxifen 20mg orally daily for 5 years
id
OG000
title
Tamoxifen
description
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Tamoxifen: Tamoxifen 20mg orally daily for 5 years Triptorelin: 3.75 mg by im injection q28 days for 5 years
id
OG001
title
T+OFS
description
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane: Exemestane 25mg orally daily for 5 years plus ovarian function suppression Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Triptorelin: 3.75 mg by im injection q28 days for 5 years
id
OG002
title
E+OFS

param Type

NUMBER

population Description

Intention-to-treat

reporting Status

POSTED

time Frame

8-year estimates, reported at a median follow-up of 8 years

title

Overall Survival

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice