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NCT01007942 · OUTCOME

Median Time to Deterioration of the ECOG Performance Status Score

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer · Source last updated 2017-04-05

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
baseline, until disease progression or death up to about 41 months

What was measured

Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, \& physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead

Analysis population: The Full Analysis Set (FAS) consisted of all randomized patients.

Groups in this outcome

Everolimus + Vinorelbine + Trastuzumab

Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Placebo + Vinorelbine + Trastuzumab

Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

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

Analysis denominator · Participants

GroupSource count
Everolimus + Vinorelbine + Trastuzumab284
Placebo + Vinorelbine + Trastuzumab285

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Vinorelbine + Trastuzumab32.66Not reported17.6832.66Not reported
Placebo + Vinorelbine + Trastuzumab21.55Not reported12.48NAN/A = data could not be analyzed at later time points due to the low number of patients.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.68
        upper Limit
        32.66
        value
        32.66
      2. comment
        N/A = data could not be analyzed at later time points due to the low number of patients.
        group Id
        OG001
        lower Limit
        12.48
        upper Limit
        NA
        value
        21.55
denoms
  1. counts
    1. group Id
      OG000
      value
      284
    2. group Id
      OG001
      value
      285
    units
    Participants
description
Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, \& physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead
dispersion Type
95% Confidence Interval
groups
  1. description
    Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
    id
    OG000
    title
    Everolimus + Vinorelbine + Trastuzumab
  2. description
    Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
    id
    OG001
    title
    Placebo + Vinorelbine + Trastuzumab
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) consisted of all randomized patients.
reporting Status
POSTED
time Frame
baseline, until disease progression or death up to about 41 months
title
Median Time to Deterioration of the ECOG Performance Status Score
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice