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NCT01007942 · OUTCOME

PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)

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

PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.

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

Deterioration - global QoL domain by at least 10%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Vinorelbine + Trastuzumab8.31Not reported6.9311.53Not reported
Placebo + Vinorelbine + Trastuzumab7.29Not reported5.5510.38Not reported
Deterioration in the PF domain by at least 10%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Vinorelbine + Trastuzumab11.96Not reported8.3114.09Not reported
Placebo + Vinorelbine + Trastuzumab12.48Not reported8.3120.86Not reported
Deterioration in the EF domain by at least 10%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Vinorelbine + Trastuzumab15.18Not reported9.2017.28Not reported
Placebo + Vinorelbine + Trastuzumab12.45Not reported9.6916.36Not reported
Deterioration in the SF domain by at least 10%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Vinorelbine + Trastuzumab11.33Not reported8.1814.52Not reported
Placebo + Vinorelbine + Trastuzumab13.11Not reported8.3119.32Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.93
        upper Limit
        11.53
        value
        8.31
      2. group Id
        OG001
        lower Limit
        5.55
        upper Limit
        10.38
        value
        7.29
    title
    Deterioration - global QoL domain by at least 10%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.31
        upper Limit
        14.09
        value
        11.96
      2. group Id
        OG001
        lower Limit
        8.31
        upper Limit
        20.86
        value
        12.48
    title
    Deterioration in the PF domain by at least 10%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.20
        upper Limit
        17.28
        value
        15.18
      2. group Id
        OG001
        lower Limit
        9.69
        upper Limit
        16.36
        value
        12.45
    title
    Deterioration in the EF domain by at least 10%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.18
        upper Limit
        14.52
        value
        11.33
      2. group Id
        OG001
        lower Limit
        8.31
        upper Limit
        19.32
        value
        13.11
    title
    Deterioration in the SF domain by at least 10%
denoms
  1. counts
    1. group Id
      OG000
      value
      284
    2. group Id
      OG001
      value
      285
    units
    Participants
description
PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.
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
PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice