Participant flow

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer · Source last updated 2026-04-30

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

groups

1. description

   Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.

   id

   FG000

   title

   Capivasertib + Fulvestrant

2. description

   Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.

   id

   FG001

   title

   Placebo + Fulvestrant

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         17

      type

      Subjective disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         209

      2. group Id

         FG001

         num Subjects

         273

      type

      Condition under investigation worsened

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         6

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      type

      Any reason not specifically recorded

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         355

      2. group Id

         FG001

         num Subjects

         353

      type

      STARTED

   2. achievements

      1. comment

         Participants ongoing capivasertib/placebo at data cut-off

         group Id

         FG000

         num Subjects

         63

      2. comment

         Participants ongoing capivasertib/placebo at data cut-off

         group Id

         FG001

         num Subjects

         43

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         292

      2. group Id

         FG001

         num Subjects

         310

      type

      NOT COMPLETED

   title

   Global Cohort

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Any reason not specifically recorded

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         47

      type

      Condition under investigation worsened

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Subjective disease progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. comment

         An additional 110 participants were enrolled into the China cohort only; 24 participants were in both the Global and China cohorts.

         group Id

         FG000

         num Subjects

         71

      2. comment

         An additional 110 participants were enrolled into the China cohort only; 24 participants were in both the Global and China cohorts.

         group Id

         FG001

         num Subjects

         63

      type

      STARTED

   2. achievements

      1. comment

         Participants ongoing capivasertib/placebo at data cut-off

         group Id

         FG000

         num Subjects

         18

      2. comment

         Participants ongoing capivasertib/placebo at data cut-off

         group Id

         FG001

         num Subjects

         10

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         53

      type

      NOT COMPLETED

   title

   China Cohort

pre Assignment Details

A total of 818 participants were enrolled in the study. However, 24 participants were in both the Global and China cohorts.

recruitment Details

A total of 708 participants in Global cohort (out of 818 participants in Global and China cohorts) were randomized to treatment. An additional 110 participants were enrolled into the China cohort only.

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

Preserved source evidence · Not medical advice