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NCT01007942 · OUTCOME

Trastuzumab Blood Concentrations by Leading Dose and Time Point

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
MEAN
Unit
ng/ml
Interval / dispersion
Standard Deviation
Time frame
Cycle 3, Day 1

What was measured

Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.

Analysis population: The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.

Groups in this outcome

Everolimus

Oral everolimus of 5 mg/day

Everolimus Placebo

Oral placebo everolimus of 5 mg/day

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

Analysis denominator · Participants

GroupSource count
Everolimus74
Everolimus Placebo59

Reported measurements

Pre-infusion - dose (Cmin) (n: 73, 57)
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus23.3516.3344Not reportedNot reportedNot reported
Everolimus Placebo24.5267.9960Not reportedNot reportedNot reported
End of infusion (Cmax) (n: 75, 59)
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus64.27927.8549Not reportedNot reportedNot reported
Everolimus Placebo60.57615.5198Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.3344
        value
        23.351
      2. group Id
        OG001
        spread
        7.9960
        value
        24.526
    title
    Pre-infusion - dose (Cmin) (n: 73, 57)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.8549
        value
        64.279
      2. group Id
        OG001
        spread
        15.5198
        value
        60.576
    title
    End of infusion (Cmax) (n: 75, 59)
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      59
    units
    Participants
description
Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.
dispersion Type
Standard Deviation
groups
  1. description
    Oral everolimus of 5 mg/day
    id
    OG000
    title
    Everolimus
  2. description
    Oral placebo everolimus of 5 mg/day
    id
    OG001
    title
    Everolimus Placebo
param Type
MEAN
population Description
The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.
reporting Status
POSTED
time Frame
Cycle 3, Day 1
title
Trastuzumab Blood Concentrations by Leading Dose and Time Point
type
SECONDARY
unit Of Measure
ng/ml

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

Preserved source evidence · Not medical advice