Participant flow

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-08-26

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

groups

1. description

   Tamoxifen 20mg orally daily for 5 years

   id

   FG000

   title

   Tamoxifen

2. description

   Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

   id

   FG001

   title

   T+OFS

3. description

   Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

   id

   FG002

   title

   E+OFS

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         146

      2. group Id

         FG001

         num Subjects

         70

      3. group Id

         FG002

         num Subjects

         135

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         114

      2. group Id

         FG001

         num Subjects

         113

      3. group Id

         FG002

         num Subjects

         77

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         33

      3. group Id

         FG002

         num Subjects

         39

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         57

      3. group Id

         FG002

         num Subjects

         49

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1021

      2. group Id

         FG001

         num Subjects

         1024

      3. group Id

         FG002

         num Subjects

         1021

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         654

      2. group Id

         FG001

         num Subjects

         751

      3. group Id

         FG002

         num Subjects

         719

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         367

      2. group Id

         FG001

         num Subjects

         273

      3. group Id

         FG002

         num Subjects

         302

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

3066 patients were randomized between 17Dec03 and 27Jan11 at 426 centers in 25 countries.

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

Preserved source evidence · Not medical advice