Participant flow

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer · Source last updated 2024-03-12

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

groups

1. description

   Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)

   id

   FG000

   title

   Ribociclib + NSAI/Tamoxifen + Goserelin

2. description

   Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin

   id

   FG001

   title

   Placebo + NSAI/Tamoxifen+ Goserelin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         234

      2. group Id

         FG001

         num Subjects

         260

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         20

      type

      Subject/guardian decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         14

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         27

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol deviation

   8. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         11

      type

      Study terminated as per protocol

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         335

      2. group Id

         FG001

         num Subjects

         337

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         17

      comment

      Participants in the placebo arm who crossed over to the ribociclib arm and received at least one dose of the crossover study treatment

      type

      Crossover Cohort

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         335

      2. group Id

         FG001

         num Subjects

         337

      type

      NOT COMPLETED

   title

   Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Subject/guardian decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         3

      type

      Study terminated as per protocol

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         7

      type

      Progressive disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         15

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Post-treatment Efficacy Follow-up

pre Assignment Details

Screening assessments were conducted up to 28 days prior to the randomization

recruitment Details

Participants were enrolled in 185 sites across 30 countries.

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

Preserved source evidence · Not medical advice