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NCT01772472 · OUTCOME

Serum Concentrations of 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 and 15-30 minutes post-infusion on Cycles 1 and 4; Treatment completion/discontinuation visit (up to approximately 64 months) (1 cycle = 21 days)

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
Trastuzumab404

Reported measurements

Pre-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab388
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
Trastuzumab384
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab20843.1Not reportedNot reportedNot reported
Pre-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab361
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab64.860.6Not reportedNot reportedNot reported
15-30 minutes post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab355
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab21847.2Not reportedNot reportedNot reported
Treatment Completion/Discontinuation

Analysis denominator · Participants

GroupSource count
Trastuzumab325
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab58.786.3Not 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
        388
      units
      Participants
    title
    Pre-infusion on Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.1
        value
        208
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.6
        value
        64.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        361
      units
      Participants
    title
    Pre-infusion on Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.2
        value
        218
    denoms
    1. counts
      1. group Id
        OG000
        value
        355
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        86.3
        value
        58.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        325
      units
      Participants
    title
    Treatment Completion/Discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      404
    units
    Participants
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 and 15-30 minutes post-infusion on Cycles 1 and 4; Treatment completion/discontinuation visit (up to approximately 64 months) (1 cycle = 21 days)
title
Serum Concentrations of Trastuzumab
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice