Participant flow

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] · Source last updated 2025-10-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).

   id

   FG000

   title

   Trastuzumab Deruxtecan (T-DXd)

2. description

   Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.

   id

   FG001

   title

   Ado-trastuzumab Emtansine (T-DM1)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         66

      2. group Id

         FG001

         num Subjects

         158

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         12

      type

      Clinical Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         17

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject (from treatment only)

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Lack of Efficacy

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         8

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      Miscellaneous

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         261

      2. group Id

         FG001

         num Subjects

         263

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         136

      2. group Id

         FG001

         num Subjects

         49

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         125

      2. group Id

         FG001

         num Subjects

         214

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 524 participants were enrolled and treated at study sites in 14 countries. Primary results reported is from first participant randomized up to data cut-off date of 21 May 2021. The results presented are based on primary analysis up to 33 months. Data collection is still on-going and additional results will be provided after study completion.

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

Preserved source evidence · Not medical advice