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NCT03403712 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
NCT03403712: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT03403712 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 404 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03403712, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
Study Summary
Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[control\]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.
Interventions
- DRUG dexamethasone
- DRUG fosnetupitant/ palonosetron
- DRUG netupitant/palonosetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2018-09-19 |
| Phase | Phase 3 |
What the finished NCT03403712 record still lists
NCT03403712 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which dexamethasone is the first listed.
NCT03403712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03403712 about?
NCT03403712 is a clinical study titled "A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer". Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[...
What is the current status of trial NCT03403712?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2018-03-16. Estimated completion is 2018-09-19.
What interventions are being tested in trial NCT03403712?
The interventions under investigation include: dexamethasone (DRUG), fosnetupitant/ palonosetron (DRUG), netupitant/palonosetron (DRUG).
Who is sponsoring clinical trial NCT03403712?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03403712's enrollment target sits among peer trials
404 914th of 2000 higher than 1,084 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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