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NCT02422615 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 726
- Enrollment target
NCT02422615 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 726 participants.
The verdict
NCT02422615, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 726 participants
- Enrollment target
Study Summary
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 726 participants |
| Start Date | 2015-06-09 |
| Est. Completion | 2023-01-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02422615
The ClinicalTrials.gov registry entry for NCT02422615 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 726 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.
NCT02422615 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02422615 about?
NCT02422615 is a clinical study titled "Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.". The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
What is the current status of trial NCT02422615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 726 participants. The study started on 2015-06-09. Estimated completion is 2023-01-11.
What interventions are being tested in trial NCT02422615?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT02422615?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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