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NCT03367572 · ClinicalTrials.gov registry record · Phase 3
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer
A Phase 3 study of Breast Carcinoma, sponsored by University of Rochester NCORP Research Base.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,363
- Enrollment target
- 18
- Study locations
NCT03367572: Completed Phase 3 study of Breast Carcinoma, sponsored by University of Rochester NCORP Research Base.
NCT03367572 is a Phase 3 study of Breast Carcinoma that has completed, run by University of Rochester NCORP Research Base. The registered enrollment target is 1,363 participants, above the 758-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (80% higher). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03367572, a Phase 3 study of Breast Carcinoma, has completed, sponsored by University of Rochester NCORP Research Base.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,363 participants
- Enrollment target
- 18
- Study locations
Study Summary
This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
Primary Outcome
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- DRUG Olanzapine
- DRUG Netupitant/Palonosetron Hydrochloride
Study Locations (18)
Wisconsin
- Saint Vincent Hospital Cancer Center Green Bay - Green Bay
- Gundersen Health System - La Crosse
- Aurora NCORP - Milwaukee
Michigan
- Michigan Cancer Research Consortium - Ann Arbor
- Cancer Research Consortium of West Michigan - Grand Rapids
Ohio
- Columbus NCORP - Columbus
- Dayton Clinical Oncology Program - Dayton
South Carolina
- Greenville NCORP - Greenville
- Upstate Carolina NCORP - Spartanburg
Hawaii
- Hawaii MU NCORP - Honolulu
Illinois
- Decatur Memorial Hospital - Decatur
Louisiana
- Gulf South MU-NCORP - New Orleans
Minnesota
- Health Partners Inc - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,363 participants |
| Start Date | 2018-04-19 |
| Est. Completion | 2024-04-13 |
| Phase | Phase 3 |
What the finished NCT03367572 record still lists
NCT03367572 is an interventional study that assigns participants to a tested intervention. Its 1,363 participants enrollment target places it among the larger protocols in the corpus, above the 758-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (80% higher).
The record links to 1 condition, with Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03367572 lists 18 locations in 13 states (Wisconsin, Michigan, Ohio).
Frequently Asked Questions
What is clinical trial NCT03367572 about?
NCT03367572 is a clinical study titled "Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer". This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. ...
What is the current status of trial NCT03367572?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,363 participants. The study started on 2018-04-19. Estimated completion is 2024-04-13.
What conditions does trial NCT03367572 study?
This clinical trial studies the following conditions: Breast Carcinoma.
What interventions are being tested in trial NCT03367572?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Olanzapine (DRUG), Netupitant/Palonosetron Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03367572?
This trial is sponsored by University of Rochester NCORP Research Base, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03367572 being conducted?
This trial has 18 study locations across Hawaii, Illinois, Louisiana, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03367572's enrollment target sits among peer trials
1,363 12th of 106 higher than 95 of 106 other Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Carcinoma 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.
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