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NCT01772472 · OUTCOME

Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)

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
nanograms per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-infusion, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days)

What was measured

Concentration of DM1 in plasma was measured through the samples obtained from participants randomized to the trastuzumab emtansine arm. DM1 is an ant-microtubule agent derived from maytansine. In transtuzumab entansine, DM1 is linked to the antibody transtuzumab thus helping the drug to specifically target the HER 2- positive cancer cells.

Analysis population: PK-evaluable population included all participants who received atleast 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 Emtansine417

Reported measurements

Pre-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine401
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab EmtansineNANANot reportedNot reportedThe geometric mean and geometric coefficient of variation were not estimable as majority of the values were lower than reportable.
15-30 minutes post-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine397
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine4.2157.4Not reportedNot reportedNot reported
2 hours post-infusion on Cycle 1

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine387
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine3.4438.2Not reportedNot reportedNot reported
Pre-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine361
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine0.372NANot reportedNot reportedThe geometric coefficient of variation was not estimable as majority of the values were lower than reportable or zero.
15-30 minutes post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine359
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine4.8148.8Not reportedNot reportedNot reported
2 hours post-infusion on Cycle 4

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine347
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine3.7041.0Not 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 majority of the values were lower than reportable.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      units
      Participants
    title
    Pre-infusion on Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.4
        value
        4.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        397
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.2
        value
        3.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      units
      Participants
    title
    2 hours post-infusion on Cycle 1
  4. categories
    1. measurements
      1. comment
        The geometric coefficient of variation was not estimable as majority of the values were lower than reportable or zero.
        group Id
        OG000
        spread
        NA
        value
        0.372
    denoms
    1. counts
      1. group Id
        OG000
        value
        361
      units
      Participants
    title
    Pre-infusion on Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.8
        value
        4.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        359
      units
      Participants
    title
    15-30 minutes post-infusion on Cycle 4
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.0
        value
        3.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        347
      units
      Participants
    title
    2 hours post-infusion on Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      417
    units
    Participants
description
Concentration of DM1 in plasma was measured through the samples obtained from participants randomized to the trastuzumab emtansine arm. DM1 is an ant-microtubule agent derived from maytansine. In transtuzumab entansine, DM1 is linked to the antibody transtuzumab thus helping the drug to specifically target the HER 2- positive cancer cells.
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
PK-evaluable population included all participants who received atleast 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, 15-30 minutes and 2 hour post-infusion on Cycles 1 and 4 (1 cycle = 21 days)
title
Plasma Concentrations of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice