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NCT04494425 · OUTCOME

Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer · Source last updated 2026-03-04

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
From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

What was measured

Blood samples were collected at indicated timepoints to determine ADA. Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline (negative or missing). Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following drug administration.

Analysis population: The ADA population included all participants who received at least 1 dose of T-DXd and who had a non-missing ADA result at any time.

Groups in this outcome

T-DXd

Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.

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

Analysis denominator · Participants

GroupSource count
T-DXd433

Reported measurements

Treatment-induced ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-DXd22Not reportedNot reportedNot reportedNot reported
Treatment-boosted ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-DXd0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Treatment-induced ADA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment-boosted ADA
denoms
  1. counts
    1. group Id
      OG000
      value
      433
    units
    Participants
description
Blood samples were collected at indicated timepoints to determine ADA. Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline (negative or missing). Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following drug administration.
groups
  1. description
    Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    OG000
    title
    T-DXd
param Type
COUNT_OF_PARTICIPANTS
population Description
The ADA population included all participants who received at least 1 dose of T-DXd and who had a non-missing ADA result at any time.
reporting Status
POSTED
time Frame
From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
title
Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice