An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

PHASE2CompletedINTERVENTIONAL
Enrollment

563

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

April 22, 2021

Study Completion Date

April 22, 2021

Conditions
Early Stage HER2+ Breast Cancer
Interventions
DRUG

Neratinib

DRUG

Loperamide

DRUG

Colestipol

2 g twice daily with or without food for one 28 day cycle

DRUG

Budesonide

9 mg extended release tablets once daily with or without food for 28 days

Trial Locations (58)

1090

Medical University of Vienna, Department of Oncology, Vienna

Medical University of Vienna,Department of Obstetrics and Gynecology, Vienna

5013

CHU Group Hospitalier Pitié-Salpêtrière, Service d'oncologie Médicale, Paris

5037

Ashford Cancer Centre Research, Kurralta Park

6009

BCRC-WA, Hollywood Private Hospital, Nedlands

8036

Univ. Klinik für Innere Medizin, Klin. Abt. Onkologie, Graz

11042

Clinical Research Alliance, Inc, Lake Success

15213

Magee-Womens Hospital of UPMC, Pittsburgh

20357

Mammazentrum HH am Krankenhaus Jerusalem, Hamburg

21201

University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore

22031

Inova Schar Cancer Institute, Fairfax

24105

Universitaetsklinikum Schleswig-Holstein, Kiel

28040

Hospital Clinico San Carlos, Madrid

29414

Charleston Hematology Oncology Associates, Charleston

29926

Saint Joseph / Candler SC Cancer Specialists, Hilton Head Island

30265

Cancer Treatment Centers of America, Newnan

33021

Memorial Healthcare System, Hollywood

33322

Baptist Health Urgent Care Sawgrass, Sunrise

33324

Florida Cancer Research Institute, LLC, Plantation

34952

Hematology-Oncology Associates of the Treasure Coast, Port Saint Lucie

35205

Alabama Oncology, Birmingham

38801

North Mississippi Medical Center Hematology and Oncology Services, Tupelo

40202

Norton Cancer Institute, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

60426

Ingalls Memorial Hospital, Harvey

62526

Decatur Memorial Hospital Cancer Care Specialists of Central Illinois, Decatur

63069

Sana Klinikum Offenbach GmbH - Frauenklinik, Offenbach

63110

Washington University School of Medicine, St Louis

69101

Great Plains Health (Callahan Cancer Center), North Platte

77030

The University of Texas MD Anderson Cancer Center, Houston

78412

Coastal Bend Cancer Center, Corpus Christi

79110

Praxis für interdisziplinäre Onkologie & Hämatologie, Freiburg im Breisgau

84106

Utah Cancer Specialists, Salt Lake City

84405

Community Cancer Trials of Utah, Ogden

90095

Ronald Reagan UCLA Medical Center, Los Angeles

90277

Torrance Memorial Physician Network Cancer Care Associates, Redondo Beach

92373

Emad Ibrahim, M.D., Inc., Redlands

92501

Compassionate Care Research Group Inc., Riverside

92705

The Oncology Institute of Hope and Innovation, Santa Ana

92835

St. Joseph Heritage Healthcare, Fullerton

92879

Compassionate Care Research Group Inc., Corona

93105

Cancer Center of Santa Barbara with Sansum Clinic, Santa Barbara

93454

Central Coast Medical Oncology Corporation, Santa Maria

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94800

Institut Gustave Roussy, Villejuif

97213

Providence Portland Medical Center, Portland

97330

Good Samaritan Hospital Samaritan Pastega Regional Cancer Center, Corvallis

04240

Central Maine Medical Center, Lewiston

07039

Saint Barnabas Medical Center, Livingston

07753

Jersey Shore University Medical Center, Neptune City

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

08035

MD Anderson Cancer Center at Cooper, Voorhees Township

Unknown

Sydney Adventist Hospital, Wahroonga

A-6020

Medical University of Innsbruck-Department of Gynecology, Innsbruck

A-5020

Uniklinikum Salzburg, Landeskrankenhaus, Univ. Klinik fur Innere Medizin III der PMU, Salzburg

M4N3M5

Sunnybrook Research Insitute, Toronto

H4A 3J1

McGill University Health Centre, Cedars Cancer Centre, Montreal

D-24106

Universitaetsklinikum Schleswig-Holstein (UKSH), Klinik fuer Gynaekologie und Geburtshilfe, Studienzentrale Gynäkologische Onkologie (SGC) Kiel, Kiel

All Listed Sponsors
lead

Puma Biotechnology, Inc.

INDUSTRY

NCT02400476 - An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide | Biotech Hunter | Biotech Hunter