Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexamethasone based mouthwash · 1 trial · 1 indication
The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.
| Arm | Type | Description |
|---|---|---|
| Dexamethasone based mouthwash | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Dexamethasone based mouthwash | DRUG | Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone. |
| Everolimus | DRUG | Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations. |
| Exemestane | DRUG | Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations. |
Inclusion Criteria: 1. Adult women \> 18 years of age with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy 2. Histological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER...
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