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NCT05161195 · ClinicalTrials.gov registry record · Phase 4
Roll-over Study to Allow Continued Access to Ribociclib
A Phase 4 study of Metastatic Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 4
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT05161195 is a Phase 4 study of Metastatic Breast Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 134 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 18 states.
The verdict
NCT05161195, a Phase 4 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (34% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT05161195 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Georgia, New Jersey, Arizona.
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.
What interventions are being tested in trial NCT05161195?
The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT05161195?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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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Related
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