Participant flow

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer · Source last updated 2017-02-06

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

groups

1. description

   5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

   id

   FG000

   title

   T+P Concomitant Anthracycline-based Chemotherapy

2. description

   FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.

   id

   FG001

   title

   T+P Sequential Anthracycline-based Chemotherapy

3. description

   Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

   id

   FG002

   title

   T+P Concomitant Non-Anthracycline Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Violation of Selection Criteria at Entry

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         10

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      type

      Refused Treatment

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Failure to Return

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Recurrence of Disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         75

      3. group Id

         FG002

         num Subjects

         77

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         60

      2. group Id

         FG001

         num Subjects

         63

      3. group Id

         FG002

         num Subjects

         60

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This study included 3 periods: Neoadjuvant (pre-operative) period and surgery, adjuvant (post-operative) period and post-treatment follow-up period.

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Preserved source evidence · Not medical advice