Participant flow

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer · Source last updated 2017-02-13

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

groups

1. description

   Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.

   id

   FG000

   title

   Dexamethasone Based Mouthwash

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      New cancer therapy

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Administrative problems

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Abnormal laboratory values

   7. reasons

      1. group Id

         FG000

         num Subjects

         10

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         86

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         50

      type

      Pharmacokinetic Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         56

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         30

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 92 participants were enrolled into the study and received study treatments of everolimus and exemestane. Of these, 86 participants were confirmed to have also received the investigational treatment of dexamethasone steroid mouthwash and comprised the full analysis set (FAS). The patient disposition is based on the FAS.

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

Preserved source evidence · Not medical advice