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NCT05161195 · ClinicalTrials.gov record · last posted 2026-06-23

Roll-over Study to Allow Continued Access to Ribociclib

StatusActive, Not Recruiting
PhasePhase 4
Started2022-07-07
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

Amendment record 40 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 40 times since 2021-12-03; most recent amendment 2026-06-22. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-06-23
Status change Recruiting→Active, Not Recruitingv29
2022-07-25
Status change Not Yet Recruiting→Recruitingv4
Trial Details
NCT Number NCT05161195
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Breast Cancer
Enrollment 134 participants
Start Date 2022-07-07
Primary Completion 2030-06-28 (estimated)
Study Completion 2030-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-06-23