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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 17, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05161195). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 134 participants (ACTUAL). Conditions: Metastatic Breast Cancer. Interventions: DRUG: Ribociclib; DRUG: Letrozole; DRUG: Anastrozole; DRUG: Goserelin; DRUG: Tamoxifen; DRUG: Fulvestrant. Primary outcome measures: Percentage of participants with treatment-emergent adverse events (AES) , From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years. Brief summary: 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).