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NCT05104866 · OUTCOME

Clinical Outcome Assessment- TTD in GHS

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) · Source last updated 2026-08-24

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 date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.

What was measured

Time to deterioration in global health status/QoL as measured by the global health status/QoL scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 decrease in score relative to baseline score.

Groups in this outcome

Dato-DXd

Arm 1: Dato-DXd

Investigator's Choice of Chemotherapy (ICC)

Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)

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

Analysis denominator · Participants

GroupSource count
Dato-DXd365
Investigator's Choice of Chemotherapy (ICC)367

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dato-DXd3.4Not reported2.15.0Not reported
Investigator's Choice of Chemotherapy (ICC)2.1Not reported1.52.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    Stratified Cox Proportional Hazards model. A hazard ratio \< 1 favours Dato-DXd.
    group Description
    Dato-DXd versus ICC
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1155
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Comment
    Adjusted for stratification factors
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    Stratified Cox Proportional Hazards model. A hazard ratio \< 1 favours Dato-DXd.
    group Description
    Dato-DXd versus ICC
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1155
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Comment
    Adjusted for stratification factors
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        5.0
        value
        3.4
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        2.9
        value
        2.1
denoms
  1. counts
    1. group Id
      OG000
      value
      365
    2. group Id
      OG001
      value
      367
    units
    Participants
description
Time to deterioration in global health status/QoL as measured by the global health status/QoL scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 decrease in score relative to baseline score.
dispersion Type
95% Confidence Interval
groups
  1. description
    Arm 1: Dato-DXd
    id
    OG000
    title
    Dato-DXd
  2. description
    Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
    id
    OG001
    title
    Investigator's Choice of Chemotherapy (ICC)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.
title
Clinical Outcome Assessment- TTD in GHS
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice