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NCT01772472 · OUTCOME

Number of Participants With Positive ADAs to 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months])

What was measured

ADA-positive participants after drug administration were determined for participants exposed to trastuzumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab was determined by summing the ADA-positive participants across all timepoints.

Analysis population: SE Population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified 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
Trastuzumab720

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Trastuzumab386
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab11Not reportedNot reportedNot reportedNot reported
Post-baseline

Analysis denominator · Participants

GroupSource count
Trastuzumab392
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    denoms
    1. counts
      1. group Id
        OG000
        value
        386
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        392
      units
      Participants
    title
    Post-baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      720
    units
    Participants
description
ADA-positive participants after drug administration were determined for participants exposed to trastuzumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result. The total number of participants who developed ADAs to trastuzumab was determined by summing the ADA-positive participants across all timepoints.
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
COUNT_OF_PARTICIPANTS
population Description
SE Population included all randomized participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
reporting Status
POSTED
time Frame
Baseline (Day1 of Cycle1) and Post Baseline (Day 1 of Cycle 4 up to 3-4 months after last dose of the drug [up to approximately 13.6 months])
title
Number of Participants With Positive ADAs to Trastuzumab
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice