Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03822468 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 376 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (183% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by local investigators according to RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
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 |
What the finished NCT03822468 record still lists
NCT03822468 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (183% higher).
The record links to 0 conditions, and to 4 interventions - of which Anastrozole is the first listed.
NCT03822468 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03822468's enrollment target sits among peer trials
376 116th of 2000 higher than 1,885 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03102125 · 376 participants · Phase 4
Allograft Dysfunction in Heart Transplant
- NCT05055297 · 376 participants · NA
SELUTION4BTK Trial
- NCT05912647 · 376 participants · NA
Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
- NCT05963971 · 376 participants · NA
A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI