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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
92
Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations.
Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.
Number of Participants With Stomatitis Grade ≥ 2
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 frame: 56 days
Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less
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.
Time frame: 56 days
Median Number of Mouthwashes Per Day
The median number of mouthwashes per day was assessed.
Time frame: 56 days
Number of Participants With All Grades of Stomatitis
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.
Time frame: 56 days
Dose Intensity of Everolimus and Exemestane
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.
Time frame: 56 days
Blood Concentration of Everolimus and Exemestane
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Highlands Oncology Group Highlands Oncology Group (22)
Fayetteville, Arkansas, United States
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim, California, United States
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States
University of California at Los Angeles UCLA and TRIO Network
Los Angeles, California, United States
University of California Irvine UC Irvine Medical Center
Orange, California, United States
University of California San Francisco UCSF Medical Center
San Francisco, California, United States
California Pacific Medical Center SC
San Francisco, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
OnCare Hawaii
‘Aiea, Hawaii, United States
...and 13 more locations
Blood samples were collected and analyzed.
Time frame: 28 days (pre-dose)