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NCT03050398 · ClinicalTrials.gov registry record · Phase 3
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
NCT03050398: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03050398 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 8 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03050398, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
Primary Outcome
Mutations of genes that were relevant to HR+ and the CDK4/6 pathway such as but not limited to CCND1, CDKN2A, PIK3CA and PTEN to identify the potential mechanisms of progression.
Interventions
- DRUG Ribociclib
- DRUG letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-06-07 |
| Est. Completion | 2019-03-08 |
| Phase | Phase 3 |
Why NCT03050398 stopped before completion
NCT03050398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ribociclib is the first listed.
NCT03050398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03050398 about?
NCT03050398 is a clinical study titled "A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib". This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
What is the current status of trial NCT03050398?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2017-06-07. Estimated completion is 2019-03-08.
What interventions are being tested in trial NCT03050398?
The interventions under investigation include: Ribociclib (DRUG), letrozole (DRUG).
Who is sponsoring clinical trial NCT03050398?
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 NCT03050398's enrollment target sits among peer trials
8 1993rd of 2000 higher than 6 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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