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

PHASE3CompletedINTERVENTIONAL
Enrollment

404

Participants

Timeline

Start Date

March 16, 2018

Primary Completion Date

September 19, 2018

Study Completion Date

September 19, 2018

Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
DRUG

fosnetupitant/ palonosetron

intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination

DRUG

netupitant/palonosetron

oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination

DRUG

dexamethasone

Oral dexamethasone (12 mg)

Trial Locations (40)

4600

JSC Saint Nikolozi Surgery and Oncological Centre, Kutaisi

15063

Monongahela Valley Hospital, Monongahela

21202

Mercy Medical Center, Medical Oncology and Hematology, Baltimore

29732

Carolina Blood and Cancer Care Associates, P.A., Rock Hill

30165

Harbin Clinic, Rome

30607

University Cancer & Blood Center, LLC, Athens

31021

Cancer Center of !\!Iiddle Georgia, Dublin

31404

Summit Cancer Care, Savannah

32763

Mid Florida Hematology and Oncology Center, Orange City

33805

Watson Clinic LLP, Lakeland

38138

The West Clinic, PC dba West Cancer Center, Germantown

39401

Hattiesburg Clinic Hematology Oncology, Hattiesburg

41101

Ashland-Bellefonte Cancer Center, Ashland

43219

Mid Ohio Oncology/Hematology Inc. DBA The Mark H. Zangmeister Center, Columbus

43623

Toledo Clinic Cancer Center - Toledo, Toledo

46845

Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne

47150

Baptist Health Cancer Center, New Albany

47904

TU Health Arnett Cancer Center, Lafayette

60076

Edward H. Kaplan MD & Associates, Skokie

60077

Presence Infusion Care - Skokie, Skokie

64804

Cornell-Beshore Cancer Institute, Joplin

65807

Cox Mcdical ·Centers, Springfield

66606

Cotton O'Neil Clinical Res. Ctr., Hematology & Oncology, Topeka

67214

Cancer Center of Kansas, Wichita

71105

CHRISTUS Cancer Treatment Center, Shreveport

72205

Carti Cancer Center, Little Rock

82001

Cheyenne Regional Medical Center, Cheyenne

85745

The Oncology Inst. Of Hope and Innovation, Tucson

87401

San Juan Oncology Associates, Farmington

90033

Hao Wei Zhang M.D., Los Angeles

90305

Uptimum Medical Group Inc., Inglewood

90805

The Oncology Institute of Hope and Innnovation, Long Beach

92373

Emad Ibrahim, MD, INC., Redlands

92801

Pacific Cancer Medical Center, Inc., Anaheim

92882

The Oncology Tnstitute of Hope and Innovation, Corona

93309

CBCC Global Research, INC at Comprehensive Blood and Cancer Center, Bakersfield

07207

Trinitas Cancer Center, Elizabeth

0159

LTD Institute of Clinical Oncology, Tbilisi

LTD Tbilisi Oncology Dispensary, Tbilisi

0179

LTD S.Khechinashvili University Hospital, Tbilisi

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Emerald Clinical Inc.

INDUSTRY

collaborator

The Physicians' Services Incorporated Foundation

OTHER

lead

Helsinn Healthcare SA

INDUSTRY