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Brief Title: 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
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 ID: NCT02069093
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
North Shore University Health System NorthShore University, Evanston, Illinois, United States
Oncology Specialists, SC Onc Specialists, Park Ridge, Illinois, United States
University of Maryland School of Medicine University of Maryland, Baltimore, Maryland, United States
Kaiser Permanente - Mid Atlantic Permanete Research Institut Kaiser Permanente Mid-Atlantic, Rockville, Maryland, United States
Karmanos Cancer Institute Karmanos Cancer Institute (2), Detroit, Michigan, United States
Saint Luke's Hospital/Marion Bloch Neuroscience Institute Cancer Institute, Kansas City, Missouri, United States
Regional Cancer Care Associates Cancer and Hematologic Disease, Cherry Hill, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2), Morristown, New Jersey, United States
M. Francisco Gonzalez, MD.PA Hematology Oncology Center, Columbia, South Carolina, United States
Oncology Consultants Oncology Consultants, P.A., Houston, Texas, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2), Houston, Texas, United States
Delta Oncology Associates Delta Hematology/Oncology, Portsmouth, Virginia, United States
Northwest Medical Specialties Northwest Medical - Puyallup, Tacoma, Washington, United States
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR