Participant flow

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer · Source last updated 2017-04-05

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

groups

1. description

   Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

   id

   FG000

   title

   Everolimus + Vinorelbine + Trastuzumab

2. description

   Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

   id

   FG001

   title

   Placebo + Vinorelbine + Trastuzumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         14

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Abnormal test procedure

   3. reasons

      1. group Id

         FG000

         num Subjects

         217

      2. group Id

         FG001

         num Subjects

         242

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      New cancer therapy

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Administrative problems

   9. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   10. reasons

       1. group Id

          FG000

          num Subjects

          4

       2. group Id

          FG001

          num Subjects

          3

       type

       Patients untreated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         284

      2. group Id

         FG001

         num Subjects

         285

      type

      STARTED

   2. achievements

      1. comment

         Pts completed= on treatment at time of DCO. Not Completed = ended treatment as per protocol.

         group Id

         FG000

         num Subjects

         3

      2. comment

         Pts completed= on treatment at time of DCO. Not Completed = ended treatment as per protocol.

         group Id

         FG001

         num Subjects

         7

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         281

      2. group Id

         FG001

         num Subjects

         278

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

284 patients randomized to the Everolimus + trastuzumab + vinorelbine arm, 280 took drug. 285 patients randomized to the placebo + trastuzumab + vinorelbine arm, 282 too drug. A total of 569 were comprised to randomized total and 562 to safety.

recruitment Details

DCO ( Data cut-off) for patient disposition is 1-Apr-2015. Each Cycle = 21 days

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

Preserved source evidence · Not medical advice