156
Participants
Start Date
May 31, 2015
Primary Completion Date
May 31, 2021
Study Completion Date
July 31, 2021
3 weeks Dose Induction of Everolimus
"Comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.~All patients will be treated within the approved indication of everolimus in combination with exemestane.~Patients will be randomized in a 1:1 ratio"
3 weeks Conventional Everolimus Dosing
"Comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.~All patients will be treated within the approved indication of everolimus in combination with exemestane.~Patients will be randomized in a 1:1 ratio"
Open Label Phase with conventional 10mg Everolimus Dosing week 4-24
All patients will receive open label Everolimus with Exemestane for 21 weeks according to label
Standard Care after 24 weeks
It is up to the discretion of the investigator to continue with Everolimus+Exemestane beyond 24 weeks
Kiel
Rotenburg (Wümme)
Bielefeld
Goslar
Essen
Cologne
Mainz
Sana Klinikum Offenbach / German Breast Group, Neu-Isenburg
Hanau
Weinheim
Karlsruhe
München
University of Erlangen, Erlangen
TU Dresden, Dresden
Collaborators (1)
Novartis
INDUSTRY
GBG Forschungs GmbH
OTHER