CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
Dexamethasone based mouthwash +2 moredrug
Likely dose
Dexamethasone based mouthwash 0.5 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02069093
NCT02069093Phase 2Completed
CompareCT.gov

A Phase II, Single Arm Study of the Use of Steroid-based Mouthwash to Prevent Stomatitis in Postmenopausal Women With Advanced or Metastatic Hormone Receptor Positive Breast Cancer Being Treated With Everolimus Plus Exemestane

Novartis Pharmaceuticals·interventional·Posted Feb 21, 2014·Updated Feb 13, 2017

In Brief

A Phase 2 clinical trial evaluating Dexamethasone based mouthwash, Everolimus, and 1 other intervention for Advanced Breast Cancer. Completed, enrolled 92 participants across 23 sites.

Detailed Summary

Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2014
Enrollment StartMay 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.4 years ago

Interventions

Dexamethasone based mouthwashdrug

Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.

Everolimusdrug

Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations.

Exemestanedrug

Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.