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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02422615 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 726 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. The Kaplan-Meier method was used to
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 |
What the finished NCT02422615 record still lists
NCT02422615 is an interventional study that assigns participants to a tested intervention. The registered 726 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02422615 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02422615's enrollment target sits among peer trials
726 490th of 2000 higher than 1,510 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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