Participant flow

Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer · Source last updated 2017-04-27

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

groups

1. description

   Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.

   id

   FG000

   title

   Observation Arm

2. description

   Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.

   id

   FG001

   title

   Herceptin 1-Year Arm

3. description

   Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.

   id

   FG002

   title

   Herceptin 2-Year Arm

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         7

      type

      Adverse Event/Intercurrent Illness

   2. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         24

      3. group Id

         FG002

         num Subjects

         17

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         542

      2. group Id

         FG001

         num Subjects

         437

      3. group Id

         FG002

         num Subjects

         445

      type

      Insufficient Therapeutic Response

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      type

      Violation of Selection Criteria at Entry

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Other Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         93

      3. group Id

         FG002

         num Subjects

         84

      type

      Refused/Did Not Cooperate/Withdrew

   7. reasons

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         62

      3. group Id

         FG002

         num Subjects

         61

      type

      Failure to Return

   8. reasons

      1. group Id

         FG000

         num Subjects

         93

      2. group Id

         FG001

         num Subjects

         84

      3. group Id

         FG002

         num Subjects

         105

      type

      Other

   milestones

   1. achievements

      1. comment

         Included all participants with available signed Informed Consent Form.

         group Id

         FG000

         num Subjects

         1697

      2. comment

         Included all participants with available signed Informed Consent Form.

         group Id

         FG001

         num Subjects

         1702

      3. comment

         Included all participants with available signed Informed Consent Form.

         group Id

         FG002

         num Subjects

         1700

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         888

      2. comment

         This milestone is not applicable to participants who were already randomized to Herceptin.

         group Id

         FG001

         num Subjects

         0

      3. comment

         This milestone is not applicable to participants who were already randomized to Herceptin.

         group Id

         FG002

         num Subjects

         0

      type

      Crossover to Adjuvant Herceptin

   3. achievements

      1. group Id

         FG000

         num Subjects

         834

      2. group Id

         FG001

         num Subjects

         994

      3. group Id

         FG002

         num Subjects

         974

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         863

      2. group Id

         FG001

         num Subjects

         708

      3. group Id

         FG002

         num Subjects

         726

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

After the release of initial study results, participants in the Observation Arm without disease recurrence were given the opportunity to cross over to receive 1 or 2 years of adjuvant Herceptin. Efficacy analyses were still performed according to original randomization.

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

Preserved source evidence · Not medical advice