Participant flow

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) · Source last updated 2026-08-24

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

groups

1. description

   Arm 1: Dato-DXd

   id

   FG000

   title

   Dato-DXd

2. description

   Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)

   id

   FG001

   title

   Investigator's Choice of Chemotherapy (ICC)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Reason unknown

   2. reasons

      1. group Id

         FG000

         num Subjects

         120

      2. group Id

         FG001

         num Subjects

         131

      type

      Ongoing in study at data cut-off date

   3. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         29

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         214

      2. group Id

         FG001

         num Subjects

         204

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         365

      2. group Id

         FG001

         num Subjects

         367

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         365

      2. group Id

         FG001

         num Subjects

         367

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice