HR positive, HER2 negative advanced breast cancer
Conditions
Interventions
Ribociclib : Participants continue ribociclib in combination with letrozole as was administered in their parent study
Letrozole : Participants continue ribociclib in combination with letrozole as was
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with treatment-emergent adverse events (AEs) [ Time Frame: From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years ]: The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment | — |
Countries
Australia, Brazil, Colombia, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, US, Vietnam
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed