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NCT01007942 · OUTCOME

Progressive-free Survival (PFS) Per Investigator Assessment

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 6 weeks until disease progression or death which ever occurred first up to about 41 months

What was measured

PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

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 + Trastuzumab7.00Not reported6.748.18Not reported
Placebo + Vinorelbine + Trastuzumab5.78Not reported5.496.90Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0067
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0067
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.74
        upper Limit
        8.18
        value
        7.00
      2. group Id
        OG001
        lower Limit
        5.49
        upper Limit
        6.90
        value
        5.78
denoms
  1. counts
    1. group Id
      OG000
      value
      284
    2. group Id
      OG001
      value
      285
    units
    Participants
description
PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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 6 weeks until disease progression or death which ever occurred first up to about 41 months
title
Progressive-free Survival (PFS) Per Investigator Assessment
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice