Participant flow

Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI · Source last updated 2018-05-30

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

groups

1. description

   Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles. Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles). If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity. Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles. If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.

   id

   FG000

   title

   Fulvestrant & Everolimus

2. description

   Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles. Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles). If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity. Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.

   id

   FG001

   title

   Fulvestrant & Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         49

      type

      Disesae progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         5

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Symptomatic progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      still on treatment

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      never start protocol therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         66

      2. group Id

         FG001

         num Subjects

         65

      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

         66

      2. group Id

         FG001

         num Subjects

         65

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 131 patients were enrolled from 23 institutions between May 2013 and November 2015.

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

Preserved source evidence · Not medical advice