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NCT03822468 · ClinicalTrials.gov registry record · Phase 2
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 376
- Enrollment target
NCT03822468 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 376 participants.
The verdict
NCT03822468, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 376 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre- and postmenopausal women with hormone receptor-positive (HR-positive), HER2-negative advanced breast cancer (aBC) who have received no prior therapy for advanced disease. Premenopausal women were required to receive goserelin in both treatment arms.
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Goserelin
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2019-06-11 |
| Est. Completion | 2024-08-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03822468
The ClinicalTrials.gov registry entry for NCT03822468 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 376 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 4 interventions - of which Anastrozole is the first listed.
NCT03822468 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03822468 about?
NCT03822468 is a clinical study titled "Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer". The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre- and postmenopausal women with hormone receptor-positive (HR-positive), ...
What is the current status of trial NCT03822468?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 376 participants. The study started on 2019-06-11. Estimated completion is 2024-08-30.
What interventions are being tested in trial NCT03822468?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT03822468?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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