Participant flow

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer · Source last updated 2025-11-28

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

groups

1. description

   Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).

   id

   FG000

   title

   Pertuzumab + Trastuzumab + Chemotherapy

2. description

   Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \[mg/kg\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\^2) + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 milligrams \[mg\]).

   id

   FG001

   title

   Placebo + Trastuzumab + Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         475

      2. group Id

         FG001

         num Subjects

         466

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         181

      2. group Id

         FG001

         num Subjects

         269

      type

      Recurrence of disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         181

      2. group Id

         FG001

         num Subjects

         176

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         46

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         42

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         32

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         28

      type

      Contralateral breast cancer

   8. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         29

      type

      Reason not specified

   milestones

   1. achievements

      1. comment

         A total of 22 participants randomized to the pertuzumab arm did not receive any study treatment.

         group Id

         FG000

         num Subjects

         2400

      2. comment

         A total of 13 participants randomized to the placebo arm did not receive any study treatment.

         group Id

         FG001

         num Subjects

         2404

      comment

      Intent-to-Treat (ITT) Population

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2340

      2. comment

         24 participants randomized to the placebo arm received at least 1 dose of pertuzumab in error. They were included in the pertuzumab arm for safety analyses.

         group Id

         FG001

         num Subjects

         24

      comment

      Pertuzumab Safety Population

      type

      Received at Least 1 Dose of Pertuzumab

   3. achievements

      1. comment

         38 participants randomized to the pertuzumab arm did not receive any pertuzumab. They were included in the placebo arm for safety analyses.

         group Id

         FG000

         num Subjects

         38

      2. group Id

         FG001

         num Subjects

         2367

      comment

      Placebo Safety Population

      type

      Received Any Study Treatment Except for Pertuzumab

   4. achievements

      1. group Id

         FG000

         num Subjects

         2369

      2. group Id

         FG001

         num Subjects

         2381

      type

      Entered Follow-Up

   5. achievements

      1. group Id

         FG000

         num Subjects

         1361

      2. group Id

         FG001

         num Subjects

         1316

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         1039

      2. group Id

         FG001

         num Subjects

         1088

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 6263 patients were screened for the study. The most common cause of screen failure was lack of confirmation of HER2-positivity by the central laboratory which accounted for approximately half of the screen failures.

recruitment Details

Overall, 4804 patients were randomized in the study, 2400 in the Pertuzumab arm and 2404 in the Placebo arm.

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Preserved source evidence · Not medical advice