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NCT01772472 · OUTCOME

Serum Concentrations of Trastuzumab Emtansine

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
micrograms per milliliter (ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-infusion on Cycles 1, 2, 4 and 5; 15-30 minutes and 2 hours post-infusion on Cycles 1 and 4; treatment discontinuation/completion visit (up to approximately 64 months) (1 cycle = 21 days)

Analysis population: Pharmacokinetic (PK)-evaluable population included all participants who received at least 1 dose of trastuzumab emtansine 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 Emtansine

Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W 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
Trastuzumab Emtansine423

Reported measurements

Pre-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine406
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab EmtansineNANANot 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
Trastuzumab Emtansine402
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine63.0101.8Not reportedNot reportedNot reported
2 hours post-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine388
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine67.460.0Not reportedNot reportedNot reported
Pre-infusion on Cycle 2

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine383
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine1.69110.7Not reportedNot reportedNot reported
Pre-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine379
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine1.7395.7Not reportedNot reportedNot reported
15-30 minutes post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine375
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine68.559.4Not reportedNot reportedNot reported
2 hours post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine358
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine66.471.0Not reportedNot reportedNot reported
Pre-infusion on Cycle 5

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine336
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine1.6799.3Not reportedNot reportedNot reported
Treatment Completion/Discontinuation

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine323
Values in micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine0.323265.3Not 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
        406
      units
      Participants
    title
    Pre-infusion on Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        101.8
        value
        63.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        402
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.0
        value
        67.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        388
      units
      Participants
    title
    2 hours post-infusion on Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        110.7
        value
        1.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        383
      units
      Participants
    title
    Pre-infusion on Cycle 2
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        95.7
        value
        1.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        379
      units
      Participants
    title
    Pre-infusion on Cycle 4
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.4
        value
        68.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        375
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.0
        value
        66.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      units
      Participants
    title
    2 hours post-infusion on Cycle 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        99.3
        value
        1.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        336
      units
      Participants
    title
    Pre-infusion on Cycle 5
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        265.3
        value
        0.323
    denoms
    1. counts
      1. group Id
        OG000
        value
        323
      units
      Participants
    title
    Treatment Completion/Discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      423
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    OG000
    title
    Trastuzumab Emtansine
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK)-evaluable population included all participants who received at least 1 dose of trastuzumab emtansine 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 Cycles 1, 2, 4 and 5; 15-30 minutes and 2 hours post-infusion on Cycles 1 and 4; treatment discontinuation/completion visit (up to approximately 64 months) (1 cycle = 21 days)
title
Serum Concentrations of Trastuzumab Emtansine
type
SECONDARY
unit Of Measure
micrograms per milliliter (ug/mL)

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Preserved source evidence · Not medical advice