202
Participants
Start Date
March 7, 2013
Primary Completion Date
December 17, 2015
Study Completion Date
January 13, 2021
Everolimus
Everolimus was self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously until progression of disease, unacceptable toxicity or withdrawal of consent.
Letrozole
1st line study treatment: Letrozole was self administered as a daily dose of 2.5mg continuously until disease progression or any other reason for which the patient might be discontinued
Exemestane
2nd Line Study Treatment: Exemestane was self administered as a daily dose of 25mg taken orally continuously until disease progression or any other reason for which the patient might be discontinued
Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study)
Alcohol-free 0.5mg/5ml dexamethasone oral solution was self-administered at a daily dose of 10ml 3 times per day (participants with confirmed stomatitis who entered the stomatitis sub-study).
Standard of care to treat stomatitis (Stomatitis sub-study)
Standard of care used to treat stomatitis at the patient's center (participants with confirmed stomatitis who entered the stomatitis sub-study).
Novartis Investigative Site, Gyula
Novartis Investigative Site, Maastricht
Novartis Investigative Site, Kecskemét
Novartis Investigative Site, Santa Rosa
Novartis Investigative Site, Szekszárd
Columbia University Medical Center- New York Presbyterian Columbia, New York
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok
Broome Oncology SC, Johnson City
Novartis Investigative Site, A Coruña
Novartis Investigative Site, Besançon
Cone Health Cancer Center, Greensboro
Novartis Investigative Site, Bordeaux
Novartis Investigative Site, Istanbul
Novartis Investigative Site, Izmir
University of Alabama Comprehensive Cancer Center SC-2, Birmingham
Novartis Investigative Site, Salamanca
Norton Healthcare Inc SC, Louisville
Novartis Investigative Site, Nantes
Novartis Investigative Site, Valencia
Novartis Investigative Site, Nancy
Novartis Investigative Site, Lyon
East Texas Hematology Clinic SC, Lufkin
Novartis Investigative Site, Le Chesnay
Novartis Investigative Site, Hyères
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City
Banner MD Anderson Cancer Center, Gilbert
University of New Mexico Hospital SC, Albuquerque
Breastlink Medical Group Dept. of BreastlinkResearchGrp, Long Beach
Loma Linda University Loma Linda, Loma Linda
Oncology Specialists, SC Advocate Medical Group-Niles, Park Ridge
St. Francis Health Comprehensive Cancer Center, Topeka
Baystate Medical Center SC-2, Springfield
Saint Barnabas Medical Center CancerCenter of Saint Barnabas, Livingston
Novartis Investigative Site, Rosario
Novartis Investigative Site, Porto Alegre
Novartis Investigative Site, São Paulo
Novartis Investigative Site, São Paulo
Novartis Investigative Site, Nagoya
Novartis Investigative Site, Sapporo
Novartis Investigative Site, Shiwa-gun
Novartis Investigative Site, Kawasaki
Novartis Investigative Site, Kumamoto
Novartis Investigative Site, Lisbon
Novartis Investigative Site, Lisbon
Novartis Investigative Site, Porto
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Antalya
Novartis Investigative Site, Bath
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY