Participant flow

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer · Source last updated 2016-10-31

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

groups

1. description

   Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.

   id

   FG000

   title

   Trastuzumab Emtansine

2. description

   Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.

   id

   FG001

   title

   Lapatinib + Capecitabine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         305

      2. group Id

         FG001

         num Subjects

         333

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician's Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         55

      type

      Subject's Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         137

      2. group Id

         FG001

         num Subjects

         98

      type

      Sponsor's Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Reason Not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         495

      2. group Id

         FG001

         num Subjects

         496

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         490

      2. group Id

         FG001

         num Subjects

         488

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         495

      2. group Id

         FG001

         num Subjects

         496

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant Overall Survival (OS) benefit in favor of trastuzumab emtansine demonstrated in second interim analysis (cut-off date 31 July 2012). The safety analysis of the arm was then reported.

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

Preserved source evidence · Not medical advice