Participant flow

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE) · Source last updated 2021-09-28

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

groups

1. description

   Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.

   id

   FG000

   title

   Placebo

2. description

   Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.

   id

   FG001

   title

   Denosumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1524

      2. group Id

         FG001

         num Subjects

         1514

      type

      Protocol-specified Criteria: Study Ended

   2. reasons

      1. group Id

         FG000

         num Subjects

         369

      2. group Id

         FG001

         num Subjects

         385

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         215

      2. group Id

         FG001

         num Subjects

         214

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         35

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         20

      type

      Noncompliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         20

      type

      Disease Progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         14

      type

      Ineligibility Determined

   8. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         11

      type

      Other

   9. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         9

      type

      Adverse Event

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          6

       type

       Administrative Decision

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Protocol Deviation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         2253

      2. group Id

         FG001

         num Subjects

         2256

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2229

      2. group Id

         FG001

         num Subjects

         2230

      type

      Received Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         28

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         2226

      2. group Id

         FG001

         num Subjects

         2228

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized in a 1:1 ratio to 1 of 2 groups. Randomization was stratified based on breast cancer therapy/lymph node (LN) status, hormone receptor status, human epidermal growth factor receptor 2 (HER-2) status, age, and geographic region.

recruitment Details

Participants were enrolled at 407 centers in Australia, Western Europe, Eastern Europe, Israel, North America, Asia, South America, South Africa, and Turkey from 02 June 2010 to 24 August 2012.

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

Preserved source evidence · Not medical advice