Participant flow

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer · Source last updated 2026-09-29

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

groups

1. description

   Participants with locally advanced human epidermal growth factor receptor 2-positive (HER2+)/metastatic breast cancer (mBC) were allocated to receive tucatinib 300 milligrams (mg) orally (PO) twice a day (BID) with trastuzumab 6 mg per kilograms (mg/kg) intravenously (IV) or at a fixed dose of 600 mg subcutaneously (SC), and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.

   id

   FG000

   title

   Tucatinib + Trastuzumab + Pertuzumab

2. description

   Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure

   id

   FG001

   title

   Placebo + Trastuzumab + Pertuzumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         33

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         299

      2. group Id

         FG001

         num Subjects

         291

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         326

      2. group Id

         FG001

         num Subjects

         328

      comment

      As Randomized.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         326

      2. group Id

         FG001

         num Subjects

         328

      type

      Intent-to-Treat (ITT) Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         326

      2. group Id

         FG001

         num Subjects

         324

      type

      Safety Analysis Set (SAS)

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         326

      2. group Id

         FG001

         num Subjects

         328

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice