Roll-over Study to Allow Continued Access to Ribociclib
Phase 4
- Conditions
- Metastatic Breast Cancer
- Registration Number
- LBCTR2022095114
- Lead Sponsor
- ovartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Percentage of participants with treatment-emergent adverse events (AES);Timepoints: From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years;Measure: 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
- Secondary Outcome Measures
Name Time Method ame: Clinical benefit rate;Timepoints: Up to 5 years;Measure: Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits