Participant flow

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

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

groups

1. description

   Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

   id

   FG000

   title

   Pertuzumab + Trastuzumab + Docetaxel

2. description

   Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

   id

   FG001

   title

   Placebo + Trastuzumab + Docetaxel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         235

      2. group Id

         FG001

         num Subjects

         280

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         53

      type

      Withdrew Consent or Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         402

      2. group Id

         FG001

         num Subjects

         406

      comment

      Intent-to-Treat (ITT) Population

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Did Not Receive Any Study Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         399

      2. comment

         9 participants randomized to the Placebo arm actually received at least one dose of pertuzumab.

         group Id

         FG001

         num Subjects

         9

      comment

      Safety Population (Pertuzumab)

      type

      Received at Least One Dose of Pertuzumab

   4. achievements

      1. comment

         1 participant randomized to the Pertuzumab arm actually received placebo at every treatment cycle.

         group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         395

      comment

      Safety Population (Placebo)

      type

      Received at Least One Dose of Placebo

   5. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         From July 2012, 50 participants randomized to Placebo arm crossed over to open-label pertuzumab.

         group Id

         FG001

         num Subjects

         50

      type

      Crossover From Placebo to Pertuzumab

   6. achievements

      1. group Id

         FG000

         num Subjects

         119

      2. group Id

         FG001

         num Subjects

         73

      comment

      Alive and in Survival Follow-up at End of Study

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         283

      2. group Id

         FG001

         num Subjects

         333

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 1196 patients were screened for the study, of whom a total of 808 participants were randomized to one of the two treatment arms.

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

Preserved source evidence · Not medical advice