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NCT01077154 · OUTCOME

Overall Survival

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 end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively.

What was measured

Overall survival (OS) time was defined as the time interval from the randomization date to the date of death from any cause. Participants last known to be alive were censored at their last contact date. Since the median time to overall survival could not be estimated at the time of the final analysis due to low numbers of events, the percentage of participants with an event (i.e., death) is reported.

Analysis population: All randomized participants

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
Placebo2253
Denosumab2256

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo9.5Not reported8.310.8Not reported
Denosumab9.5Not reported8.310.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.22
    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
    0.94
    param Type
    Hazard Ratio (HR)
    param Value
    1.01
    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
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.22
    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
    0.94
    param Type
    Hazard Ratio (HR)
    param Value
    1.01
    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
        8.3
        upper Limit
        10.8
        value
        9.5
      2. group Id
        OG001
        lower Limit
        8.3
        upper Limit
        10.7
        value
        9.5
denoms
  1. counts
    1. group Id
      OG000
      value
      2253
    2. group Id
      OG001
      value
      2256
    units
    Participants
description
Overall survival (OS) time was defined as the time interval from the randomization date to the date of death from any cause. Participants last known to be alive were censored at their last contact date. Since the median time to overall survival could not be estimated at the time of the final analysis due to low numbers of events, the percentage of participants with an event (i.e., 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
All randomized participants
reporting Status
POSTED
time Frame
From randomization until the end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively.
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