Participant flow

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.

groups

1. description

   Participants received T-DXd 5.4 milligram per kilogram (mg/kg) via intravenous (IV) infusion every 3 weeks until disease progression (PD), unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.

   id

   FG000

   title

   T-DXd

2. description

   Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg per meter square \[m\^2\] 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 every week \[qw\] 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

   FG001

   title

   Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         160

      2. group Id

         FG001

         num Subjects

         166

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         40

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         265

      2. group Id

         FG001

         num Subjects

         223

      type

      Ongoing at the time of PCD

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         436

      2. group Id

         FG001

         num Subjects

         430

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         434

      2. group Id

         FG001

         num Subjects

         417

      type

      Randomized and Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         436

      2. group Id

         FG001

         num Subjects

         430

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

866 participants were randomized in a 1:1 ratio to receive trastuzumab deruxtecan (T-DXd) or standard of care: Investigator's choice single agent chemotherapy (capecitabine, paclitaxel or nab-paclitaxel). As pre-specified in the protocol and statistical analysis plan (SAP), results are presented by treatment group.

recruitment Details

This Phase III, multi-center, open-label study was conducted in participants with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor-positive (HR+) breast cancer at 273 sites in 28 countries. Results are presented based on primary completion date (PCD) of up to 18 March 2024.

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Preserved source evidence · Not medical advice