Participant flow

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) · Source last updated 2024-03-04

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

groups

1. description

   Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.

   id

   FG000

   title

   Trastuzumab + Taxane

2. description

   Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.

   id

   FG001

   title

   Trastuzumab Emtansine + Placebo

3. description

   Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.

   id

   FG002

   title

   Trastuzumab Emtansine + Pertuzumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         11

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         12

      type

      Reason not Specified

   5. reasons

      1. group Id

         FG000

         num Subjects

         133

      2. group Id

         FG001

         num Subjects

         144

      3. group Id

         FG002

         num Subjects

         143

      type

      Sponsor Decision to Terminate Study

   6. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         29

      3. group Id

         FG002

         num Subjects

         25

      type

      Subject/ Guardian Decision to Withdraw

   7. reasons

      1. group Id

         FG000

         num Subjects

         170

      2. group Id

         FG001

         num Subjects

         176

      3. group Id

         FG002

         num Subjects

         169

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         365

      2. group Id

         FG001

         num Subjects

         367

      3. group Id

         FG002

         num Subjects

         363

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         355

      2. group Id

         FG001

         num Subjects

         365

      3. group Id

         FG002

         num Subjects

         360

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         365

      2. group Id

         FG001

         num Subjects

         367

      3. group Id

         FG002

         num Subjects

         363

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice