NCT02069093

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Dexamethasone based mouthwash	Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
DRUG	Everolimus	Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations.
DRUG	Exemestane	Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-02-21
• Last updated: 2017-02-13
• Results posted: 2017-02-13

Locations

23 sites across 1 country: United States