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NCT03734029 · OUTCOME

Overall Survival (OS) in All Patients

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] · Source last updated 2025-10-06

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 the date of randomization up to the date of death due to any cause, up to approximately 3 years

What was measured

Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.

Analysis population: Overall survival (OS) was assessed in the Full Analysis Set (defined as all randomized participants).

Groups in this outcome

Trastuzumab Deruxtecan (T-DXd)

Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.

Physician's Choice

Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.

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)373
Physician's Choice184

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan (T-DXd)23.4Not reported20.024.8Not reported
Physician's Choice16.8Not reported14.520.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.0
        upper Limit
        24.8
        value
        23.4
      2. group Id
        OG001
        lower Limit
        14.5
        upper Limit
        20.0
        value
        16.8
denoms
  1. counts
    1. group Id
      OG000
      value
      373
    2. group Id
      OG001
      value
      184
    units
    Participants
description
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
    id
    OG000
    title
    Trastuzumab Deruxtecan (T-DXd)
  2. description
    Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
    id
    OG001
    title
    Physician's Choice
param Type
MEDIAN
population Description
Overall survival (OS) was assessed in the Full Analysis Set (defined as all randomized participants).
reporting Status
POSTED
time Frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years
title
Overall Survival (OS) in All Patients
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice