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
Public ClinicalTrials.gov record NCT03403712. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03403712
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 404 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 16, 2018 (Actual)
- Primary completion
- Sep 19, 2018 (Actual)
- Completion
- Sep 19, 2018 (Actual)
- Last update posted
- Jun 1, 2020
2018
United States locations
- U.S. sites
- 36
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Oncology Inst. Of Hope and Innovation | Tucson | Arizona | 85745 | — |
| Carti Cancer Center | Little Rock | Arkansas | 72205 | — |
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | — |
| CBCC Global Research, INC at Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| The Oncology Tnstitute of Hope and Innovation | Corona | California | 92882 | — |
| Uptimum Medical Group Inc. | Inglewood | California | 90305 | — |
| The Oncology Institute of Hope and Innnovation | Long Beach | California | 90805 | — |
| Hao Wei Zhang M.D. | Los Angeles | California | 90033 | — |
| Emad Ibrahim, MD, INC. | Redlands | California | 92373 | — |
| Watson Clinic LLP | Lakeland | Florida | 33805 | — |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | — |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | — |
| Cancer Center of !\!Iiddle Georgia | Dublin | Georgia | 31021 | — |
| Harbin Clinic | Rome | Georgia | 30165 | — |
| Summit Cancer Care | Savannah | Georgia | 31404 | — |
| Edward H. Kaplan MD & Associates | Skokie | Illinois | 60076 | — |
| Presence Infusion Care - Skokie | Skokie | Illinois | 60077 | — |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46845 | — |
| TU Health Arnett Cancer Center | Lafayette | Indiana | 47904 | — |
| Baptist Health Cancer Center | New Albany | Indiana | 47150 | — |
| Cotton O'Neil Clinical Res. Ctr., Hematology & Oncology | Topeka | Kansas | 66606 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Ashland-Bellefonte Cancer Center | Ashland | Kentucky | 41101 | — |
| CHRISTUS Cancer Treatment Center | Shreveport | Louisiana | 71105 | — |
| Mercy Medical Center, Medical Oncology and Hematology | Baltimore | Maryland | 21202 | — |
| Hattiesburg Clinic Hematology Oncology | Hattiesburg | Mississippi | 39401 | — |
| Cornell-Beshore Cancer Institute | Joplin | Missouri | 64804 | — |
| Cox Mcdical ·Centers | Springfield | Missouri | 65807 | — |
| Trinitas Cancer Center | Elizabeth | New Jersey | 07207 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Mid Ohio Oncology/Hematology Inc. DBA The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | — |
| Toledo Clinic Cancer Center - Toledo | Toledo | Ohio | 43623 | — |
| Monongahela Valley Hospital | Monongahela | Pennsylvania | 15063 | — |
| Carolina Blood and Cancer Care Associates, P.A. | Rock Hill | South Carolina | 29732 | — |
| The West Clinic, PC dba West Cancer Center | Germantown | Tennessee | 38138 | — |
| Cheyenne Regional Medical Center | Cheyenne | Wyoming | 82001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03403712, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2020 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03403712 live on ClinicalTrials.gov.