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NCT00556374 · OUTCOME

Disease-free Survival (DFS)

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy · Source last updated 2023-07-27

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the DFS data cut-off date of 15 September 2015; maximum time on main study at the cut-off was 102 months

What was measured

DFS was defined as the time interval from the randomization date to the date of first evidence of local or distant metastases, contra-lateral breast cancer, secondary carcinoma, or death from any cause (whichever occurred first). Participants last known to be alive, who did not experience recurrence of disease, were censored at their last contact date or at the data cut-off date whichever came first.

Analysis population: Full Analysis Set: all randomized participants

Groups in this outcome

Placebo

Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.

Denosumab

Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.

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

Analysis denominator · Participants

GroupSource count
Placebo1709
Denosumab1711

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PlaceboNANot reportedNANANot reached due to the low number of events
DenosumabNANot reportedNANANot reached due to the low number of events

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
    1.00
    estimate Comment
    From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0515
    param Type
    Hazard Ratio (HR)
    param Value
    0.816
    statistical Comment
    Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).
    statistical Method
    Cox Proportional Hazards Model
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.00
    estimate Comment
    From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0515
    param Type
    Hazard Ratio (HR)
    param Value
    0.816
    statistical Comment
    Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).
    statistical Method
    Cox Proportional Hazards Model
classes
  1. categories
    1. measurements
      1. comment
        Not reached due to the low number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Not reached due to the low number of events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1709
    2. group Id
      OG001
      value
      1711
    units
    Participants
description
DFS was defined as the time interval from the randomization date to the date of first evidence of local or distant metastases, contra-lateral breast cancer, secondary carcinoma, or death from any cause (whichever occurred first). Participants last known to be alive, who did not experience recurrence of disease, were censored at their last contact date or at the data cut-off date whichever came first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    OG000
    title
    Placebo
  2. description
    Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    OG001
    title
    Denosumab
param Type
MEDIAN
population Description
Full Analysis Set: all randomized participants
reporting Status
POSTED
time Frame
From randomization until the DFS data cut-off date of 15 September 2015; maximum time on main study at the cut-off was 102 months
title
Disease-free Survival (DFS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice