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

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Advanced Breast Cancer
Interventions
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.

Trial Locations (23)

20850

Kaiser Permanente - Mid Atlantic Permanete Research Institut Kaiser Permanente Mid-Atlantic, Rockville

23704

Delta Oncology Associates Delta Hematology/Oncology, Portsmouth

29203

M. Francisco Gonzalez, MD.PA Hematology Oncology Center, Columbia

30265

Southeastern Regional Medical Center, Newnan

48201

Karmanos Cancer Institute Karmanos Cancer Institute (2), Detroit

60201

North Shore University Health System NorthShore University, Evanston

64111

Saint Luke's Hospital/Marion Bloch Neuroscience Institute Cancer Institute, Kansas City

72703

Highlands Oncology Group Highlands Oncology Group (22), Fayetteville

77024

Oncology Consultants Oncology Consultants, P.A., Houston

90017

Los Angeles Hematology/Oncology Medical Group, Los Angeles

92807

Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C, Anaheim

92868

University of California Irvine UC Irvine Medical Center, Orange

94101

University of California San Francisco UCSF Medical Center, San Francisco

94115

California Pacific Medical Center SC, San Francisco

96701

OnCare Hawaii, ‘Aiea

98405

Northwest Medical Specialties Northwest Medical - Puyallup, Tacoma

90095-6956

University of California at Los Angeles UCLA and TRIO Network, Los Angeles

06030-3940

University of Connecticut Health Center, Farmington

60068-0736

Oncology Specialists, SC Onc Specialists, Park Ridge

21201-1559

University of Maryland School of Medicine University of Maryland, Baltimore

08003

Regional Cancer Care Associates Cancer and Hematologic Disease, Cherry Hill

07962

Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2), Morristown

77030-4009

University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2), Houston

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY