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NCT03734029 · OUTCOME

Number of Overall Survival Events (Deaths)

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
NUMBER
Unit
events (deaths)
Interval / dispersion
Not reported
Time frame
From the date of randomization up to the date of death due to any cause, up to approximately 3 years

Analysis population: Overall survival events (deaths) were analyzed 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 events (deaths) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan (T-DXd)149Not reportedNot reportedNot reportedNot reported
Physician's Choice90Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        90
denoms
  1. counts
    1. group Id
      OG000
      value
      373
    2. group Id
      OG001
      value
      184
    units
    Participants
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
NUMBER
population Description
Overall survival events (deaths) were analyzed 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
Number of Overall Survival Events (Deaths)
type
SECONDARY
unit Of Measure
events (deaths)

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

Preserved source evidence · Not medical advice