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NCT05104866 · OUTCOME

Progression-Free Survival

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
On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months

What was measured

PFS is defined as time from randomization until progression per RECIST 1.1, as assessed by BICR, or death due to any cause. The analysis will include all randomized participants as randomized regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1.

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-DXd6.9Not reported5.77.4Not reported
Investigator's Choice of Chemotherapy (ICC)4.9Not reported4.25.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    0.80
    estimate Comment
    Stratified Cox Proportional Hazards model. A hazard ratio \< 1 favours Dato-DXd.
    group Description
    Dato-DXd vs ICC
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95% Confidence Interval 2-Sided 0.52 to 0.76
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Comment
    Adjusted for stratification factors
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    0.80
    estimate Comment
    Stratified Cox Proportional Hazards model. A hazard ratio \< 1 favours Dato-DXd.
    group Description
    Dato-DXd vs ICC
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    95% Confidence Interval 2-Sided 0.52 to 0.76
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Comment
    Adjusted for stratification factors
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        7.4
        value
        6.9
      2. group Id
        OG001
        lower Limit
        4.2
        upper Limit
        5.5
        value
        4.9
denoms
  1. counts
    1. group Id
      OG000
      value
      365
    2. group Id
      OG001
      value
      367
    units
    Participants
description
PFS is defined as time from randomization until progression per RECIST 1.1, as assessed by BICR, or death due to any cause. The analysis will include all randomized participants as randomized regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1.
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
On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months
title
Progression-Free Survival
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice