Participant flow

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. · Source last updated 2026-02-27

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

groups

1. description

   Patients received fulvestrant (Faslodex™) 500 milligrams (mg), administered as two 5 milliliters (mL) intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).

   id

   FG000

   title

   Fulvestrant 500 mg

2. description

   Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).

   id

   FG001

   title

   Anastrozole 1 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         147

      2. group Id

         FG001

         num Subjects

         145

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         41

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         12

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Eligibility criteria not fulfilled

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         230

      2. group Id

         FG001

         num Subjects

         232

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         31

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         205

      2. group Id

         FG001

         num Subjects

         201

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

524 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. 62 patients were not randomised, mainly due to eligibility criteria not being fulfilled (44/62 patients) or patient decision (13/62 patients). 462 patients were randomised to receive treatment.

recruitment Details

First patient enrolled: 17 October 2012.

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Preserved source evidence · Not medical advice