Study Description
This is an open-label, multi-center, roll-over study to evaluate the long term safety of
ribociclib in combination with other drugs in participants who are participating in a
Novartis sponsored global study, that has fulfilled requirements for its primary
objective(s), and who in the opinion of the Investigator, would benefit from continued
treatment. The purpose of this study is to evaluate long-term safety and provide continued treatment
to participants who are currently receiving ribociclib in combination with other drugs in
a parent study, that has fulfilled requirements for its primary objective(s), and in the
opinion of the Investigator, would benefit from continuing treatment at time of
discontinuation from the parent study
Interventions
Anastrozole
Fulvestrant
Goserelin
Letrozole
Ribociclib
Tamoxifen
Eligibility Criteria
Key inclusion Criteria:
1. Currently participating in a Novartis sponsored global study (parent study),
receiving treatment with ribociclib in combination with other drugs, and the parent
study has fulfilled its primary objective(s)
2. Must have been receiving treatment with ribociclib for at least 6 cycles in the
parent study
3. Currently has evidence of clinical benefit as determined by the Investigator
Key exclusion Criteria:
1. Permanent discontinuation of ribociclib in the parent study
2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted
in the parent study 3. Local access to commercially available ribociclib and
reimbursed
Other protocol-defined inclusion/exclusion criteria may apply at the end
Worldwide Contacts
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