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NCT03734029 · OUTCOME

Duration of Response in Participants With HER2-low Breast Cancer (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 the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years

What was measured

Duration of Response (DoR) is defined as the date of the first documented objective response (complete response \[CR\] or partial response \[PR\]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method.

Analysis population: Duration of response was assessed in the Full Analysis Set.

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

BICR: DoR
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan (T-DXd)10.7Not reported8.513.2Not reported
Physician's Choice6.8Not reported6.09.9Not reported
Investigator: DoR
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan (T-DXd)8.3Not reported7.09.9Not reported
Physician's Choice5.6Not reported3.76.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.5
        upper Limit
        13.2
        value
        10.7
      2. group Id
        OG001
        lower Limit
        6.0
        upper Limit
        9.9
        value
        6.8
    title
    BICR: DoR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        9.9
        value
        8.3
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        6.6
        value
        5.6
    title
    Investigator: DoR
denoms
  1. counts
    1. group Id
      OG000
      value
      373
    2. group Id
      OG001
      value
      184
    units
    Participants
description
Duration of Response (DoR) is defined as the date of the first documented objective response (complete response \[CR\] or partial response \[PR\]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method.
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
Duration of response was assessed in the Full Analysis Set.
reporting Status
POSTED
time Frame
From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
title
Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice