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NCT03529110 · OUTCOME

Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] · Source last updated 2025-10-21

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
Up to 33 months (data cut-off)

What was measured

Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

Analysis population: Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.

Groups in this outcome

Trastuzumab Deruxtecan (T-DXd)

Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).

Ado-trastuzumab Emtansine (T-DM1)

Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab Deruxtecan (T-DXd)261
Ado-trastuzumab Emtansine (T-DM1)263

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan (T-DXd)NANot reportedNANAMedian and 95% CI was not estimable due insufficient number of events.
Ado-trastuzumab Emtansine (T-DM1)NANot reportedNANAMedian and 95% CI was not estimable due insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% CI was not estimable due insufficient number of events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median and 95% CI was not estimable due insufficient number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      261
    2. group Id
      OG001
      value
      263
    units
    Participants
description
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    OG000
    title
    Trastuzumab Deruxtecan (T-DXd)
  2. description
    Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
    id
    OG001
    title
    Ado-trastuzumab Emtansine (T-DM1)
param Type
MEDIAN
population Description
Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
reporting Status
POSTED
time Frame
Up to 33 months (data cut-off)
title
Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice