301
Participants
Start Date
June 30, 2012
Primary Completion Date
November 30, 2013
Study Completion Date
November 30, 2013
Exemestane
Exemestane is supplied by Novartis until Everolimus is commercially available for the study setting. Afterwards the investigator will prescribe Exemestane according to the individual label. Commercially available Exemestane will be supplied as tablets of 25 mg strength for oral administration. Complete guidelines for management and administration of Exemestane can be found in the package insert. Exemestane will be dosed starting on treatment Day 1. Patients will be instructed to take 1 tablet of 25 mg Exemestane orally. Package insert instructions should be followed. On the first day of each cycle, patients will receive an adequate drug supply (before commercial availability) or a prescription (after commercial availability) for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take Exemestane exactly as prescribed.
Everolimus (RAD001)
Everolimus (RAD001) is supplied by Novartis until Everolimus is commercially available for the study setting. Afterwards the investigator will prescribe Everolimus according to the individual label. Everolimus is formulated as tablets of 10 and 5 mg strength for oral administration. All study medication will be packaged into blister packs. The blisters should be opened only at the time of administration, as the drugs are both hygroscopic and light sensitive. Everolimus will be dosed starting on treatment Day 1. Patients will be instructed to take 1 tablet × 10 mg Everolimus orally with a large glass of water once daily at the same time each day with or without food. On the first day of each cycle, patients will receive an adequate drug supply (before commercial availability) or a prescription (after commercial availability) for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take Everolimus exactly as prescribed.
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Berlin
Novartis Investigative Site, Fürstenwalde
Novartis Investigative Site, Rostock
Novartis Investigative Site, Stralsund
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Lüneburg
Novartis Investigative Site, Eutin
Novartis Investigative Site, Kiel
Novartis Investigative Site, Kiel
Novartis Investigative Site, Oldenburg
Novartis Investigative Site, Bremen
Novartis Investigative Site, Hanover
Novartis Investigative Site, Lemgo
Novartis Investigative Site, Gütersloh
Novartis Investigative Site, Kassel
Novartis Investigative Site, Marburg
Novartis Investigative Site, Fulda
Novartis Investigative Site, Braunschweig
Novartis Investigative Site, Goslar
Novartis Investigative Site, Magdeburg
Novartis Investigative Site, Düsseldorf
Novartis Investigative Site, Mönchengladbach
Novartis Investigative Site, Wuppertal
Novartis Investigative Site, Velbert
Novartis Investigative Site, Bochum
Novartis Investigative Site, Essen
Novartis Investigative Site, Essen
Novartis Investigative Site, Mülheim
Novartis Investigative Site, Recklinghausen
Novartis Investigative Site, Bottrop
Novartis Investigative Site, Münster
Novartis Investigative Site, Cologne
Novartis Investigative Site, Cologne
Novartis Investigative Site, Bergisch Gladbach
Novartis Investigative Site, Aachen
Novartis Investigative Site, Bonn
Novartis Investigative Site, Bonn
Novartis Investigative Site, Troisdorf
Novartis Investigative Site, Trier
Novartis Investigative Site, Mainz
Novartis Investigative Site, Soest
Novartis Investigative Site, Frankfurt
Novartis Investigative Site, Frankfurt
Novartis Investigative Site, Langen
Novartis Investigative Site, Speyer
Novartis Investigative Site, Mannheim
Novartis Investigative Site, Heidelberg
Novartis Investigative Site, Stuttgart
Novartis Investigative Site, Gerlingen
Novartis Investigative Site, Böblingen
Novartis Investigative Site, Tübingen
Novartis Investigative Site, Esslingen am Neckar
Novartis Investigative Site, Villingen-Schwenningen
Novartis Investigative Site, Singen
Novartis Investigative Site, Freiburg im Breisgau
Novartis Investigative Site, München
Novartis Investigative Site, München
Novartis Investigative Site, München
Novartis Investigative Site, München
Novartis Investigative Site, Rosenheim
Novartis Investigative Site, Augsburg
Novartis Investigative Site, Augsburg
Novartis Investigative Site, Donauwörth
Novartis Investigative Site, Memmingen
Novartis Investigative Site, Ravensburg
Novartis Investigative Site, Nuremberg
Novartis Investigative Site, Fürth
Novartis Investigative Site, Erlangen
Novartis Investigative Site, Amberg
Novartis Investigative Site, Mühlhausen
Novartis Investigative Site, Chemnitz
Novartis Investigative Site, Dresden
Novartis Investigative Site, Gera
Novartis Investigative Site, Halle
Novartis Investigative Site, Halle
Novartis Investigative Site, Jena
Novartis Investigative Site, Plauen-Kauschwitz
Novartis Investigative Site, Weißenfels
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY