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
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|ClinicalTrials.gov Identifier: NCT02069093|
Recruitment Status : Completed
First Posted : February 21, 2014
Results First Posted : February 13, 2017
Last Update Posted : February 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: Dexamethasone based mouthwash Drug: Everolimus Drug: Exemestane||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Dexamethasone based mouthwash
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.
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.
- Number of Participants With Stomatitis Grade ≥ 2 [ Time Frame: 56 days ]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.
- Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less [ Time Frame: 56 days ]The number of days to achieve resolution of stomatitis from grade 2 or greater to grade 1 or less was assessed. 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.
- Median Number of Mouthwashes Per Day [ Time Frame: 56 days ]The median number of mouthwashes per day was assessed.
- Number of Participants With All Grades of Stomatitis [ Time Frame: 56 days ]The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. 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.
- Dose Intensity of Everolimus and Exemestane [ Time Frame: 56 days ]The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.
- Blood Concentration of Everolimus and Exemestane [ Time Frame: 28 days (pre-dose) ]Blood samples were collected and analyzed.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069093
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|