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NCT04494425 · OUTCOME

Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

What was measured

Time to deterioration was defined as the time from randomization until the date of the first clinically meaningful deterioration that was confirmed at next available assessment, at least 14 days apart, regardless of whether the participant withdrew from study treatment or receives another anti-cancer therapy prior to deterioration.

Analysis population: The ITT population included all randomized participants.

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.

Chemotherapy

Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) 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-DXd436
Chemotherapy430

Reported measurements

Physical Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd18.0Not reported15.9NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Chemotherapy9.9Not reported6.915.2Not reported
Role Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd10.3Not reported6.914.6Not reported
Chemotherapy5.5Not reported4.16.9Not reported
Emotional Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd28.2Not reported18.6NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Chemotherapy17.3Not reported12.4NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Cognitive Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd11.8Not reported8.316.6Not reported
Chemotherapy9.9Not reported7.813.8Not reported
Social Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd11.7Not reported7.616.3Not reported
Chemotherapy7.7Not reported6.210.4Not reported
Fatigue
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd4.3Not reported3.47.7Not reported
Chemotherapy2.9Not reported2.24.2Not reported
Pain
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd22.0Not reported17.2NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Chemotherapy6.3Not reported4.89.6Not reported
Nausea/Vomiting
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd3.5Not reported2.85.6Not reported
Chemotherapy13.8Not reported7.721.5Not reported
Global Health Status/QoL
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd11.3Not reported8.314.7Not reported
Chemotherapy10.5Not reported7.713.3Not reported
Dyspnea
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd20.0Not reported19.3NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Chemotherapy20.8Not reported13.1NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Loss of Appetite
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd8.3Not reported5.011.7Not reported
Chemotherapy13.8Not reported9.616.1Not reported
Insomnia
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXdNANot reported17.3NANA indicated that the median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Chemotherapy15.2Not reported12.4NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Constipation
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd9.2Not reported5.512.5Not reported
Chemotherapy22.0Not reported15.9NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Diarrhea
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd29.0Not reported17.2NANA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Chemotherapy16.5Not reported13.923.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        15.9
        upper Limit
        NA
        value
        18.0
      2. group Id
        OG001
        lower Limit
        6.9
        upper Limit
        15.2
        value
        9.9
    title
    Physical Functioning
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.9
        upper Limit
        14.6
        value
        10.3
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        6.9
        value
        5.5
    title
    Role Functioning
  3. categories
    1. measurements
      1. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        18.6
        upper Limit
        NA
        value
        28.2
      2. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        12.4
        upper Limit
        NA
        value
        17.3
    title
    Emotional Functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        16.6
        value
        11.8
      2. group Id
        OG001
        lower Limit
        7.8
        upper Limit
        13.8
        value
        9.9
    title
    Cognitive Functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.6
        upper Limit
        16.3
        value
        11.7
      2. group Id
        OG001
        lower Limit
        6.2
        upper Limit
        10.4
        value
        7.7
    title
    Social Functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.4
        upper Limit
        7.7
        value
        4.3
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        4.2
        value
        2.9
    title
    Fatigue
  7. categories
    1. measurements
      1. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        17.2
        upper Limit
        NA
        value
        22.0
      2. group Id
        OG001
        lower Limit
        4.8
        upper Limit
        9.6
        value
        6.3
    title
    Pain
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        5.6
        value
        3.5
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        21.5
        value
        13.8
    title
    Nausea/Vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        14.7
        value
        11.3
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        13.3
        value
        10.5
    title
    Global Health Status/QoL
  10. categories
    1. measurements
      1. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        19.3
        upper Limit
        NA
        value
        20.0
      2. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        13.1
        upper Limit
        NA
        value
        20.8
    title
    Dyspnea
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.0
        upper Limit
        11.7
        value
        8.3
      2. group Id
        OG001
        lower Limit
        9.6
        upper Limit
        16.1
        value
        13.8
    title
    Loss of Appetite
  12. categories
    1. measurements
      1. comment
        NA indicated that the median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        17.3
        upper Limit
        NA
        value
        NA
      2. comment
        NA indicated that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        12.4
        upper Limit
        NA
        value
        15.2
    title
    Insomnia
denoms
  1. counts
    1. group Id
      OG000
      value
      436
    2. group Id
      OG001
      value
      430
    units
    Participants
description
Time to deterioration was defined as the time from randomization until the date of the first clinically meaningful deterioration that was confirmed at next available assessment, at least 14 days apart, regardless of whether the participant withdrew from study treatment or receives another anti-cancer therapy prior to deterioration.
dispersion Type
95% Confidence Interval
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
  2. description
    Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
The ITT population included all randomized participants.
reporting Status
POSTED
time Frame
From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
title
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice