502
Participants
Start Date
October 24, 2016
Primary Completion Date
December 11, 2018
Study Completion Date
February 6, 2020
ribociclib
All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
letrozole
All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
goserelin
Premenopausal patients additionally received goserelin 3.6mg as monthly implant
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Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY