Participant flow

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] · Source last updated 2026-02-27

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 standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), 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 standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.

   id

   FG001

   title

   Trastuzumab+Capecitabine

3. description

   Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.

   id

   FG002

   title

   Lapatinib+Capecitabine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         174

      2. group Id

         FG001

         num Subjects

         64

      3. group Id

         FG002

         num Subjects

         77

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         9

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         10

      type

      Clinical Progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Miscellaneous

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Deviation

   10. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          4

       3. group Id

          FG002

          num Subjects

          3

       type

       Randomized But Not Treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         406

      2. group Id

         FG001

         num Subjects

         91

      3. group Id

         FG002

         num Subjects

         111

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         406

      2. group Id

         FG001

         num Subjects

         91

      3. group Id

         FG002

         num Subjects

         111

      type

      Randomized

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         3

      type

      Randomized But Not Treated

   4. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      comment

      Completed = Participants who are on-going study treatment as of 30 Jun 22, Not Completed = Participants who discontinued treatment and participants randomized but not treated.

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         312

      2. group Id

         FG001

         num Subjects

         90

      3. group Id

         FG002

         num Subjects

         107

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants in The Physician's Choice (TPC) group were randomized to 1 of the following 2 regimens: trastuzumab/capecitabine or lapatinib/capecitabine. As prespecified in the protocol, participants were assessed and reported separately per comparator arm for the disposition, baseline characteristics, and safety tables. For efficacy assessments, all participants in the TPC group were combined and assessed together.

recruitment Details

A total of 608 participants were enrolled at study sites in 15 countries. Primary results reported is from first participant randomized up to data cut-off date of 30 Jun 2022. The results presented are based on primary analysis up to 46 months.

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Preserved source evidence · Not medical advice