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NCT04494425 · OUTCOME

Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer · Source last updated 2026-03-04

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
Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)

What was measured

PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.

Analysis population: The HER2-low population included the subset of participants in the ITT population with HER2 immunohistochemistry (IHC) 2+/ in situ hybridization (ISH)- and IHC 1+ as determined per the interactive response technology (IRT) data for HER2 IHC expression.

Groups in this outcome

T-DXd

Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.

Chemotherapy

Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.

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

Analysis denominator · Participants

GroupSource count
T-DXd359
Chemotherapy354

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-DXd13.2Not reported11.415.2Not reported
Chemotherapy8.1Not reported7.09.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.75
    estimate Comment
    HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
    statistical Comment
    The analysis was performed using the stratified log-rank test.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.75
    estimate Comment
    HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
    statistical Comment
    The analysis was performed using the stratified log-rank test.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.4
        upper Limit
        15.2
        value
        13.2
      2. group Id
        OG001
        lower Limit
        7.0
        upper Limit
        9.0
        value
        8.1
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      354
    units
    Participants
description
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    OG000
    title
    T-DXd
  2. description
    Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
The HER2-low population included the subset of participants in the ITT population with HER2 immunohistochemistry (IHC) 2+/ in situ hybridization (ISH)- and IHC 1+ as determined per the interactive response technology (IRT) data for HER2 IHC expression.
reporting Status
POSTED
time Frame
Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
title
Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice