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NCT01958021 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 668
- Enrollment target
NCT01958021 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 668 participants.
The verdict
NCT01958021, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 668 participants
- Enrollment target
Study Summary
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.
Interventions
- DRUG Placebo
- DRUG Letrozole
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 668 participants |
| Start Date | 2013-12-17 |
| Est. Completion | 2023-03-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01958021
The ClinicalTrials.gov registry entry for NCT01958021 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 668 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01958021 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01958021 about?
NCT01958021 is a clinical study titled "Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer". The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment f...
What is the current status of trial NCT01958021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 668 participants. The study started on 2013-12-17. Estimated completion is 2023-03-16.
What interventions are being tested in trial NCT01958021?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT01958021?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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