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NCT01077154 · OUTCOME

Disease-free Survival (DFS) in the Postmenopausal Subset

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE) · Source last updated 2021-09-28

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
From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.

What was measured

DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date. Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence. Since the median DFS time in the postmenopausal subset could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported.

Analysis population: Randomized participants postmenopausal at enrollment, defined as: * Undergone bilateral oophorectomy * Age ≥ 60 years * Age 45 to 59 years with 1 of the criteria, ie, either amenorrhea \> 12 months with an intact uterus and ≥ 1 intact ovary; or amenorrhea for ≤ 12 months and follicle-stimulating hormone and estradiol in postmenopausal range.

Groups in this outcome

Placebo

Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.

Denosumab

Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.

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

Analysis denominator · Participants

GroupSource count
Placebo1088
Denosumab1061

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo18.6Not reported16.320.9Not reported
Denosumab20.3Not reported17.822.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.36
    estimate Comment
    Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.26
    param Type
    Hazard Ratio (HR)
    param Value
    1.12
    statistical Comment
    Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.
    statistical Method
    Stratified Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.36
    estimate Comment
    Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.26
    param Type
    Hazard Ratio (HR)
    param Value
    1.12
    statistical Comment
    Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.
    statistical Method
    Stratified Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.3
        upper Limit
        20.9
        value
        18.6
      2. group Id
        OG001
        lower Limit
        17.8
        upper Limit
        22.7
        value
        20.3
denoms
  1. counts
    1. group Id
      OG000
      value
      1088
    2. group Id
      OG001
      value
      1061
    units
    Participants
description
DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date. Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence. Since the median DFS time in the postmenopausal subset could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
    id
    OG000
    title
    Placebo
  2. description
    Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
    id
    OG001
    title
    Denosumab
param Type
NUMBER
population Description
Randomized participants postmenopausal at enrollment, defined as: * Undergone bilateral oophorectomy * Age ≥ 60 years * Age 45 to 59 years with 1 of the criteria, ie, either amenorrhea \> 12 months with an intact uterus and ≥ 1 intact ovary; or amenorrhea for ≤ 12 months and follicle-stimulating hormone and estradiol in postmenopausal range.
reporting Status
POSTED
time Frame
From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
title
Disease-free Survival (DFS) in the Postmenopausal Subset
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice