The purpose of this study was to determine whether treatment with tamoxifen or a
non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free
survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in
premenopausal women with hormone receptor positive (HR+), human epidermal growth factor
receptor 2 negative (HER2-) advanced breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT02278120.
See trial information on ClinicalTrials.gov for a list of participating sites.
This was a randomized, Phase III, double-blind, global study comparing the treatment
efficacy and safety of ribociclib + goserelin + tamoxifen or a NSAI (letrozole or
anastrozole) versus placebo + goserelin + tamoxifen or a NSAI in premenopausal women with
HR+, HER2- advanced breast cancer.
Eligible participants were randomized in a 1:1 ratio to either the ribociclib arm or the
placebo arm. Study treatment continued until disease progression, unacceptable toxicity,
death, or discontinuation for any other reason.
Participants who discontinued treatment due to reasons other than disease progression or
withdrawal of consent for efficacy follow-up continued to be monitored until disease
progression, death, withdrawal of consent, loss to follow-up, or subject/guardian
decision (post-treatment efficacy follow-up).
All participants who discontinued treatment were followed for survival until the
predetermined number of overall survival (OS) events was reached.
Following the final OS analysis (performed when approximately 189 deaths were recorded)
and with protocol amendment 6 (dated 18-Jul-2019), participants and investigators were
unblinded and those participants in the placebo arm had the opportunity to cross-over to
the ribociclib arm to receive ribociclib + goserelin + NSAI. Cross-over was optional and
was conducted at the investigator's discretion and upon participant consent.
Lead OrganizationNovartis Pharmaceuticals Corporation