SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

PHASE3CompletedINTERVENTIONAL
Enrollment

237

Participants

Timeline

Start Date

May 10, 2017

Primary Completion Date

June 8, 2018

Study Completion Date

May 6, 2019

Conditions
NeutropeniaBreast Cancer
Interventions
DRUG

SPI-2012

Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

DRUG

Pegfilgrastim

Subcutaneous injection administered on Day 2 of each cycle.

DRUG

Docetaxel

75mg/m\^2 IV infusion administered on Day 1 of each cycle

DRUG

Cyclophosphamide

600mg/m\^2 IV infusion administered on Day 1 of each cycle

Trial Locations (74)

1062

Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly, Budapest

1115

Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly, Budapest

1122

"Orszagos Onkologiai Intezet, B Belgyogyaszati Onkologiai Osztaly", Budapest

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum, Miskolc

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly, Nyíregyháza

7100

Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly, Szekszárd

10408

National Cancer Center, IIsan-ro

13496

Cha Bundang Medical Center, Yatap-ro

22332

Inha University Hospital, Inhang-ro

23704

Delta Hematology/Oncology Associates, Portsmouth

26426

Wonju Severance Christian Hospital, Ilsan-ro

26506

West Virginia University, Morgantown

27518

Waverly Hematology Oncology, Cary

28054

Gaston Hematology & Oncology Associates, PC, Gastonia

29732

Carolina Blood and Cancer Care Associates, Rock Hill

30905

Dwight D. Eisenhower Army Medical Center, Fort Gordon

31021

Cancer Center of Middle Georgia, Dublin

31904

John B. Amos Cancer Center, Columbus

32763

Mid-Florida Hematology and Oncology Centers, Orange City

33014

Lakes Research, LLC, Miami Lakes

33024

Millennium Oncology, Pembroke Pines

33324

BRCR Medical Center Inc, Plantation

33709

Pinellas Hematology and Oncology, St. Petersburg

33880

Bond & Steele Clinic, PA., Winter Haven

34691

Pasco Pinellas Cancer Center, Holiday

38138

The West Clinic, PC, d/b/a West Cancer Center, Germantown

39401

Hattiesburg Clinic Hematology/Oncology, Hattiesburg

40422

Commonwealth Hematology-Oncology, PSC, Danville

44501

St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC, Youngstown

44710

Aultman Hospital, Canton

45219

The Christ Hospital Cancer Center, Cincinnati

46237

FPN Oncology and Hematology Specialists, Indianapolis

48073

Quest Research Institute, Royal Oak

56303

Coborn Cancer Center, Saint Cloud

59102

St. Vincent Frontier Cancer Center, Billings

60068

Oncology Specialists, SC, Park Ridge

64804

Freeman Health Systems, Joplin

68803

CHI Health St Francis, St Francis Cancer Treatment Center, Grand Island

70433

Pontchartrain Cancer Center, Covington

71913

Genesis Cancer Center, Hot Springs

75701

HOPE Cancer Center of East Texas, Tyler

77802

CHI St Joseph Health Cancer Center, Bryan

78041

Envision Cancer Center, LLC, Laredo

78503

Texas Oncology, PA- McAllen South 2nd Street, McAllen

80204

Denver Health & Hospital Authority, Denver

83706

Saint Alphonsus Regional Medical Center, Boise

85364

Yuma Regional Cancer Center, Yuma

85715

ACRC/ Arizona Clinical Research Center Inc., Tucson

90017

Los Angeles Hematology Oncology Medical Group, Los Angeles

90603

Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation, Whittier

90813

Pacific Shores Medical Group, Long Beach

92262

Desert Regional Medical Center, Palm Springs

92373

Emad Ibrahim, MD, INC., Redlands

92708

Compassionate Care Research Group, Inc., Fountain Valley

92801

Pacific Cancer Medical Center, Inc., Anaheim

93720

California Cancer Associates for Research and Excellence Inc., Fresno

98201

Providence Regional Center Partnership, Everett

98405

Northwest Medical Specialties, PLLC, Tacoma

411011

KEM Hospital Research Centre, Pune

632004

Christian Medical College, Vellore

Arkansas

"NEA Baptist Clinic , Fowler Family Center for Cancer Care"

J4V 2H1

CISSS de la Montérégie-Centre, Longueuil

H3T 1E2

Jewish General Hospital, Montreal

15-027

BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej, Bialystok

86-300

Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej, Grudziądz

93-338

Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej, Lodz

60-569

Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu, Poznan

47-400

Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii, Racibórz

35-021

MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów

71-730

Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin

06351

Samsung Medical Center, Irwon-ro

03080

Seoul National University Hospital, Daehwa-ro

02841

Korea University Anam Hospital, Inchon-ro

03722

Severance Hospital, Yonsei-ro

All Listed Sponsors
lead

Spectrum Pharmaceuticals, Inc

INDUSTRY

NCT02953340 - SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide | Biotech Hunter | Biotech Hunter