Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01007942 · OUTCOME

Overall Survival (OS)

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
Every 3 months until death up to 41 months

What was measured

OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.

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 + Trastuzumab23.46Not reported20.0128.81Not reported
Placebo + Vinorelbine + Trastuzumab24.08Not reported21.4927.63Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.01
        upper Limit
        28.81
        value
        23.46
      2. group Id
        OG001
        lower Limit
        21.49
        upper Limit
        27.63
        value
        24.08
denoms
  1. counts
    1. group Id
      OG000
      value
      284
    2. group Id
      OG001
      value
      285
    units
    Participants
description
OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.
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
Every 3 months until death up to 41 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice