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Roll-over Study to Allow Continued Access to Ribociclib
NCT05161195 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Goserelin
- DRUG Ribociclib
Study Locations (20)
Georgia
- Summit Cancer Care — Savannah
- John D Archbold Memorial Hospital — Thomasville
New Jersey
- Englewood Health — Englewood
- The Valley Hospital-Luckow Pavillion — Paramus
Arizona
- Ironwood Cancer and Research Centers — Chandler
Arkansas
- Highlands Oncology Group — Fayetteville
California
- Beverly Hills Cancer Center — Beverly Hills
Colorado
- Poudre Valley Hospital — Fort Collins
Florida
- Mid Florida Hematology And Onc Ctr — Orange
Illinois
- Duly Health and Care — Plainfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2030-08-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05161195
The ClinicalTrials.gov registry entry for NCT05161195 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Tamoxifen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05161195 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Georgia, New Jersey, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05161195 about?
NCT05161195 is a clinical study titled "Roll-over Study to Allow Continued Access to Ribociclib". 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 No...
What is the current status of trial NCT05161195?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 134 participants. The study started on 2022-07-07. Estimated completion is 2030-08-14.
What conditions does trial NCT05161195 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05161195?
The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05161195?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05161195 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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