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NCT02732119 · ClinicalTrials.gov registry record · Phase 1
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
NCT02732119: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02732119 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02732119, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
Study Summary
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a reasonably possible relationship to the study medication(s) and is unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) and meets any of the criteria defined in the protocol. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used fo
Interventions
- DRUG Exemestane
- DRUG Everolimus
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2016-06-14 |
| Est. Completion | 2020-02-25 |
| Phase | Phase 1 |
What the finished NCT02732119 record still lists
NCT02732119 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).
The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.
NCT02732119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02732119 about?
NCT02732119 is a clinical study titled "Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.". The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor
What is the current status of trial NCT02732119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2016-06-14. Estimated completion is 2020-02-25.
What interventions are being tested in trial NCT02732119?
The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT02732119?
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 NCT02732119's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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