Roll-over Study to Allow Continued Access to Ribociclib

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Ribociclib
* Drug: Letrozole
* Drug: Anastrozole
* Drug: Goserelin
* Drug: Tamoxifen
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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Key inclusion Criteria: 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) Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study Currently has evidence of clinical benefit as determined by the Investigator Key exclusion Criteria: Permanent discontinuation of ribociclib in the parent study 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ribociclib<br>All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study. | Drug: Ribociclib<br>* Participants continue ribociclib as was administered in their parent study<br>Drug: Letrozole<br>* Participants continue ribociclib in combination with letrozole as was administered in their parent study<br>Drug: Anastrozole<br>* Participants continue ribociclib in combination with anastrozole as was administered in their parent study<br>Drug: Goserelin<br>* Participants continue ribociclib in combination with goserelin as was administered in their parent study<br>Drug: Tamoxifen<br>* Participants continue ribociclib in combination with tamoxifen as was administered in their parent study<br>Drug: Fulvestrant<br>* All participants continue ribociclib in combination with fulvestrant as was administered in their parent study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with treatment-emergent adverse events (AES) | 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 | From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate | Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roll-over Protocol, Ribociclib, HR-positive, HER2-negative, Breast Cancer, Ribociclib in combination with other drugs, LEE011