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NCT01772472 · OUTCOME

Serum Concentrations of Total Trastuzumab

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days)

What was measured

Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm.

Analysis population: PK-evaluable population included all participants who received at least 1 dose of trastuzumab and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.

Groups in this outcome

Trastuzumab

Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab421

Reported measurements

Pre-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab390
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
TrastuzumabNANANot reportedNot reportedThe geometric mean and geometric coefficient of variation were not estimable as the samples were below the limit of quantification. The samples were taken prior to administration of the first dose.
15-30 minutes post-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab418
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab71.8154.7Not reportedNot reportedNot reported
2 hours post-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab50
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab81.474.3Not reportedNot reportedNot reported
Pre-infusion on Cycle 2

Analysis denominator · Participants

GroupSource count
Trastuzumab42
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab7.93256.8Not reportedNot reportedNot reported
Pre-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab391
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab13.778.0Not reportedNot reportedNot reported
15-30 minutes post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab361
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab76.946.5Not reportedNot reportedNot reported
2 hours post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab37
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab81.534.0Not reportedNot reportedNot reported
Pre-infusion on Cycle 5

Analysis denominator · Participants

GroupSource count
Trastuzumab31
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab8.90125.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The geometric mean and geometric coefficient of variation were not estimable as the samples were below the limit of quantification. The samples were taken prior to administration of the first dose.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        390
      units
      Participants
    title
    Pre-infusion on Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        154.7
        value
        71.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        418
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.3
        value
        81.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    2 hours post-infusion on Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        256.8
        value
        7.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Pre-infusion on Cycle 2
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.0
        value
        13.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        391
      units
      Participants
    title
    Pre-infusion on Cycle 4
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.5
        value
        76.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        361
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.0
        value
        81.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    2 hours post-infusion on Cycle 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        125.0
        value
        8.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pre-infusion on Cycle 5
denoms
  1. counts
    1. group Id
      OG000
      value
      421
    units
    Participants
description
Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    OG000
    title
    Trastuzumab
param Type
GEOMETRIC_MEAN
population Description
PK-evaluable population included all participants who received at least 1 dose of trastuzumab and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.
reporting Status
POSTED
time Frame
Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days)
title
Serum Concentrations of Total Trastuzumab
type
SECONDARY
unit Of Measure
ug/mL

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Preserved source evidence · Not medical advice