Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00066690 · OUTCOME

Disease-free 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
5-year estimates, reported at a median follow-up of 67 months.

What was measured

Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.

Analysis population: Intention-to-treat

Groups in this outcome

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)

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)

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

Analysis denominator · Participants

GroupSource count
Tamoxifen1018
T+OFS1015
E+OFS1014

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tamoxifen84.7Not reported82.286.9Not reported
T+OFS86.6Not reported84.288.7Not reported
E+OFS89Not reported86.890.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    Tamoxifen was the reference group in the estimation of the hazard ratio.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    estimate Comment
    Tamoxifen was the reference group in the estimation of the hazard ratio.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    Tamoxifen was the reference group in the estimation of the hazard ratio.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    estimate Comment
    Tamoxifen was the reference group in the estimation of the hazard ratio.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.2
        upper Limit
        86.9
        value
        84.7
      2. group Id
        OG001
        lower Limit
        84.2
        upper Limit
        88.7
        value
        86.6
      3. group Id
        OG002
        lower Limit
        86.8
        upper Limit
        90.9
        value
        89
denoms
  1. counts
    1. group Id
      OG000
      value
      1018
    2. group Id
      OG001
      value
      1015
    3. group Id
      OG002
      value
      1014
    units
    Participants
description
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tamoxifen 20mg orally daily for 5 years
    id
    OG000
    title
    Tamoxifen
  2. 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)
    id
    OG001
    title
    T+OFS
  3. 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)
    id
    OG002
    title
    E+OFS
param Type
NUMBER
population Description
Intention-to-treat
reporting Status
POSTED
time Frame
5-year estimates, reported at a median follow-up of 67 months.
title
Disease-free Survival
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice