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NCT05104866 · OUTCOME

Duration of Response (DoR) as Assessed by Investigator Assessment

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 first response until progression or death. Tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months

What was measured

Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by Investigator assessment or death due to any cause.

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-DXd134
Investigator's Choice of Chemotherapy (ICC)81

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dato-DXd7.2Not reported5.78.6Not reported
Investigator's Choice of Chemotherapy (ICC)6.0Not reported4.77.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        8.6
        value
        7.2
      2. group Id
        OG001
        lower Limit
        4.7
        upper Limit
        7.7
        value
        6.0
denoms
  1. counts
    1. group Id
      OG000
      value
      134
    2. group Id
      OG001
      value
      81
    units
    Participants
description
Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by Investigator assessment or death due to any cause.
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 first response until progression or death. Tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months
title
Duration of Response (DoR) as Assessed by Investigator Assessment
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice