Participant flow

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer · Source last updated 2021-01-13

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

groups

1. description

   Patients receive oral anastrozole once daily on days 1-28. anastrozole: Given orally

   id

   FG000

   title

   Arm I Anastrozole

2. description

   Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses. anastrozole: Given orally fulvestrant: Given intramuscularly

   id

   FG001

   title

   Arm II Anastrozole and Fulvestrant

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         12

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         8

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         18

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         269

      2. group Id

         FG001

         num Subjects

         274

      type

      Progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         15

      type

      Still on treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Delinquent

   7. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         19

      type

      Not protocol specified

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Under review

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         345

      2. group Id

         FG001

         num Subjects

         349

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         345

      2. group Id

         FG001

         num Subjects

         349

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

707 Patients underwent randomization. 12 were excluded: 9 did not have metastatic disease, 1 had previous chemotherapy, 1 was estrogen-receptor and progesterone-receptor negative, 1 did not undergo chest imaging. In addition, 1 patient withdrew consent. 694 patients were included in the analysis.

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Preserved source evidence · Not medical advice