Participant flow

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.

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

   FG000

   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

   FG001

   title

   Physician's Choice

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         220

      2. group Id

         FG001

         num Subjects

         130

      type

      Progressive disease as per RECIST v1.1

   2. reasons

      1. group Id

         FG000

         num Subjects

         60

      2. group Id

         FG001

         num Subjects

         14

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         8

      type

      Clinical progression by investigator

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         12

      type

      Randomized, but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         373

      2. group Id

         FG001

         num Subjects

         184

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         373

      2. group Id

         FG001

         num Subjects

         184

      type

      Full Analysis Set (All Randomized Patients)

   3. achievements

      1. group Id

         FG000

         num Subjects

         371

      2. group Id

         FG001

         num Subjects

         172

      type

      Safety Analysis Set (All Randomized Patients Who Received at Least 1 Dose of Study Treatment)

   4. achievements

      1. group Id

         FG000

         num Subjects

         58

      2. group Id

         FG001

         num Subjects

         3

      comment

      Ongoing as of 11 Jan 2022

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         315

      2. group Id

         FG001

         num Subjects

         181

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting. The treatment chosen for the Physician's Choice arm was based on the label approved in the country of drug administration. The Physician's Choice group was combined to ensure an appropriate sample size for the comparator group.

recruitment Details

A total of 557 participants were enrolled and randomized to treatment at 161 study sites in the United States (27 study sites), Japan (18 sites), France (16 sites), China (15 sites), Italy (13 sites), Spain (12 sites), Greece (8 sites), Portugal (8 sites), Republic of Korea (8 sites), Israel (6 sites), Switzerland (6 sites), Austria (4 sites), Belgium (4 sites), Russia (3 sites), Sweden (3 sites), Taiwan (3 sites), Unted Kingdom (3 sites), Canada (2 sites), and Hungary (2 sites).

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Preserved source evidence · Not medical advice