Participant flow

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer · Source last updated 2026-08-11

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

groups

1. description

   Trastuzumab deruxtecan (5.4 mg/kg Q3W for 8 cycles)

   id

   FG000

   title

   Arm A

2. description

   Trastuzumab deruxtecan (5.4 mg/kg Q3W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles

   id

   FG001

   title

   Arm B

3. description

   Doxorubicin (60 mg/m2 Q2W) and cyclophosphamide (600 mg/m2 Q2W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles

   id

   FG002

   title

   Arm C

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         9

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         21

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      type

      As recorded on the Case Report Form (CRF).

   4. reasons

      1. group Id

         FG000

         num Subjects

         266

      2. group Id

         FG001

         num Subjects

         313

      3. group Id

         FG002

         num Subjects

         288

      type

      Ongoing at the time of primary analysis for pCR

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         286

      2. group Id

         FG001

         num Subjects

         321

      3. group Id

         FG002

         num Subjects

         320

      comment

      927

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      comment

      0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         286

      2. group Id

         FG001

         num Subjects

         321

      3. group Id

         FG002

         num Subjects

         320

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eligible patients had histologically documented human epidermal growth factor receptor 2 (HER2) - positive early stage breast cancer. Eligible patients were randomized in a 1:1:1 ratio using an interactive response technology (IRT) to receive either Arm A: Trastuzumab deruxtecan (T-DXd), Arm B: Trastuzumab deruxtecan followed by Paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) or Arm C: Doxorubicin + cyclophosphamide followed by Paclitaxel + trastuzumab + pertuzumab (ddAC-THP).

recruitment Details

The study is active, not recruiting and conducted in 18 countries worldwide across 147 centres, with 927 patients who were randomized up until 24th April 2024. Results are reported for the study at the data cut-off for the primary analysis for pathologic complete response (pCR) on 12th March 2025.

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

Preserved source evidence · Not medical advice