Participant flow

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-02-06

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

groups

1. description

   Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

   id

   FG000

   title

   T+OFS

2. description

   Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

   id

   FG001

   title

   E+OFS

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         83

      2. group Id

         FG001

         num Subjects

         116

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         126

      2. group Id

         FG001

         num Subjects

         78

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         43

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         75

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1334

      2. group Id

         FG001

         num Subjects

         1338

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1034

      2. group Id

         FG001

         num Subjects

         1026

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         300

      2. group Id

         FG001

         num Subjects

         312

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries.

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

Preserved source evidence · Not medical advice