Conditions: Advanced Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 92
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Dexamethasone based mouthwash intervention 2: Everolimus intervention 3: Exemestane
Intervention descriptions: intervention 1: Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone. intervention 2: Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations. intervention 3: Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.

Protocol document: