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NCT00556374 · OUTCOME

Bone Metastases-free Survival (BMFS)

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 end of main study, maximum time on main study was 152 months

What was measured

BMFS was defined as the time interval from randomization to first occurrence of bone metastasis or death from any cause, whichever comes first. Participants last known to be alive, who did not experience bone metastasis, were censored at their last assessment (i.e., bone scan) date or at the last contact date, whichever comes 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
    0.654
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.997
    estimate Comment
    A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.808
Complete source fields
analyses
  1. ci Lower Limit
    0.654
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.997
    estimate Comment
    A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.808
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
BMFS was defined as the time interval from randomization to first occurrence of bone metastasis or death from any cause, whichever comes first. Participants last known to be alive, who did not experience bone metastasis, were censored at their last assessment (i.e., bone scan) date or at the last contact date, whichever comes 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 end of main study, maximum time on main study was 152 months
title
Bone Metastases-free Survival (BMFS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice