Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

September 26, 2013

Primary Completion Date

October 28, 2016

Study Completion Date

October 28, 2016

Conditions
Breast TumorBreast CancerCancer of the BreastEstrogen Receptor- Negative Breast CancerHER2- Negative Breast CancerProgesterone Receptor- Negative Breast CancerRecurrent Breast CancerStage IV Breast CancerTriple-negative Breast CancerTriple-negative Metastatic Breast CancerMetastatic Breast Cancer
Interventions
DRUG

nab-Paclitaxel

nab-Paclitaxel 125 mg/m\^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.

DRUG

Carboplatin

Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day treatment cycle.

Trial Locations (140)

144

Istituto Nazionale Tumori Regina Elena, Roma

1090

Medizinische Universitat Wien, Vienna

2605

Canberra Hospital, Garran

3199

Frankston Hospital Oncology Research, Frankston

3690

Border Medical Oncology, Wodonga

5020

Salzburger Landkliniken St. Johanns-Spital, Salzburg

6009

Sir Charles Gairdner Hospital, Nedlands

6020

Universitaetsklinik Innsbruck, Innsbruck

8035

Hospital Universitario Vall D Hebron, Barcelona

10021

Clinical Research Alliance, New York

10126

Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Piemonte

10713

Sankt Gertrauden-Krankenhaus, Berlin

11042

NYU Langone Arena Oncology, Lake Success

11528

University of Athens Medical school - Regional General Hospital, Athens

13057

Hematology Oncology Associates of CNY, East Syracuse

14004

Hospital Universitario Reina Sofia, Córdoba

15213

Magee Women's Hospital, Pittsburgh

15562

IASO General, Athens

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

16132

IRCCS AziendaOspedaliera Universitaria San Martino, Genova

18547

Metropolitan Hospital, Faliro

19047

St Mary Medical Center, Langhorne

20014

Onkologikoa - Kutxaren Institutu Onkologikoa, Donostia / San Sebastian

20089

Istituto Clinico Humanitas, Rozzano (MI)

20817

Center for Cancer and Blood Disorders, PC, Bethesda

20900

Azienda Ospedaliera San Gerardo, Monza

21201

University of Maryland School of Med, Baltimore

22408

Hematology Oncology Associates of Fredericksburg, Fredericksburg

23230

Virginia Cancer Institute, Richmond

23704

Delta Hematologyoncology Associates, Portsmouth

24047

Azienda Ospedaliera Treviglio-Caravaggio, Treviglio

25701

Edwards Comprehensive Cancer Center, Huntington

26500

University General Hospital of Patras, Rio Patras

28007

Hospital General Gregorio Maranon, Madrid

29210

South Carolina Oncology Associates, Columbia

31134

Frauenarzte am Bahnhofsplatz, Hildesheim

32224

Mayo Clinic - Jacksonville, Jacksonville

33021

Memorial Breast Cancer Center, Hollywood

33136

University of Miami School of Medicine, Miami

33401

Florida Cancer Specialists, West Palm Beach

33486

Center for Hematology-Oncology, Boca Raton

33705

Florida Cancer Specialists, St. Petersburg

34232

Florida Cancer Specialists, Sarasota

35128

Istituto Oncologico Veneto, Padua

37203

Sarah Cannon Cancer Center, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, Emilia-Romagna

41071

Hospital Universitario Virgen Macarena, Seville

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

43219

Mark H Zangmeister Center, Columbus

43623

Toledo Community Oncology Program, Toledo

44124

Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna, Ferrara

45219

University of Cincinnatti, Cincinnati

45242

Oncology Hematology Care, Cincinnati

46254

Investigative Clinical Research of Indiana, LLC, Indianapolis

50009

Hospital Universitario Miguel Servet, Zaragoza

50679

Schwerpunktpraxis fur Gynakologische Onkologie, Cologne

53111

Facharztpraxis fur Gynakologie und Geburtshilfe, Bonn

53211

Columbia St Marys Cancer Center, Milwaukee

54290

Krankenanstalt Mutterhaus der Borromaerinnen, Trier

54301

Saint Vincent Hospital, Green Bay

55407

Minnesota Oncology Hematology, PA, Minneapolis

55905

Mayo Clinic, Rochester

58100

Presidio Ospedaliero della Misericordia, Grosseto

60431

Agaplesion Markus Krankenhaus, Frankfurt

60435

Joliet Oncology-Hematology Associates, Ltd, Joliet

61801

Carle Cancer Center, Urbana

63003

Centre Jean Perrin, Clermont-Ferrand

63131

Missouri Baptist Medical Center, St Louis

64132

Midwest Physicians Group, Kansas City

69120

Universitaetsklinikum Heidelberg, Heidelberg

70503

University of South Alabama Mitchell Cancer Institute, Lafayette

71110

University General Hospital of Heraklion, Heraklion

72703

Highlands Oncology Group, Fayetteville

73505

Cancer Centers of Southwest Oklahoma, Lawton

75231

Texas Oncology, PA, Dallas

75246

Texas Oncology, PA- Dallas, Dallas

75702

Texas Oncology P.A.- Tyler, Tyler

76104

The Center for Cancer and Blood Disorders, Fort Worth

77030

UT Physicians General Medicine, Houston

78217

Cancer Care Centers of South Texas - Loop, San Antonio

79110

Praxis fur interdisziplinare Onkologie & Hamatologie, Freiburg im Breisgau

80131

Azienda Ospedaliera Universitaria Federico II, Napoli, Campania

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale, Napoli, Campania

81377

LMU Klinikum der Universitat, München

85224

Ironwood Cancer and Research Center, Chandler

85251

Arizona Cancer Research Alliance, Scottsdale

85259

Mayo Clinic Arizona, Scottsdale

85306

Arizona Center for Cancer Care, Glendale

89075

Universitatsklinikum Ulm, Ulm

90045

Translational Research Management, Los Angeles

91750

Wilshire Oncology Medical Group, Inc, La Verne

92025

California Cancer Associates for Research and Excellence cCARE, Escondido

92093

University of California San Diego Moores Cancer Center, La Jolla

92801

Pacific Cancer Medical Center Inc, Anaheim

93401

Coastal Integrative Cancer Care, San Luis Obispo

93454

Central Coast Medical Oncology Corporation, Santa Maria

95403

Redwood Regional Medical Group, INC, Santa Rosa

97213

Northwest Cancer Specialists, P.C. - Hoyt, Portland

Providence Portland Medical Center, Portland

97420

North Bend Medical Center, Coos Bay

98158

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte, Messina

99208

Medical Oncology Associates, Spokane

48202-268

Henry Ford Medical Center - New Center One, Detroit

03106

New Hampshire Oncology Hematology, Hooksett

03756

Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center, Lebanon

07631

Englewood Hospital and Medical Center, Englewood

27215-8700

Alamance Regional Medical Cancer Center, Burlington

41820-021

Centro de Oncologia Da Bahia, Salvador

81520-060

Liga Paranaense de Combate Ao Cancer, Curitiba

20560-120

Instituto Nacional de Cancer - INCA, Rio de Janerio

90035-001

Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos

17210-080

Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú, Jau/SP

60160-230

ONCOCLINIC Clinica de Oncologia LTDA, Fortaleza

14015-130

Instituto Ribeiraopretano de Combate Ao Cancer, Ribeirão Preto

14048-900

Hospital das Clinicas da Faculdade de Medicina da USP, Ribeirão Preto

95900-000

Hospital Bruno Born, Rio Grande

15090-000

Hospital de Base Da Faculdade de Medicina de, São José do Rio Preto

01308-050

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo

03102-002

Instituto Brasileiro de Controle Do Cancer IBCC, São Paulo

05651-901

Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira, São Paulo

K1H 8L6

Ottawa General Hospital, Ottawa

H2L 4M1

CHUM - Notre Dame, Montreal

G1S4L8

Hospital du Saint Scarement Sacrement Laboratory, Québec

G5L5T1

CSSS de Rimouski Neigette, Rimouski

S4T1A5

Alan Blair Cancer Centre at Pasqua Hosptial, Regina

00168

Policlinico Universitario A Gemelli, Roma

00189

Azienda Ospedaliera Sant Andrea, Roma

7000-811

Hospital Espirito Santo, Evora

1500-650

Hospital Da Luz, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

4200-072

Instituto Portugues de Oncologia do Porto, Francisco Gentil, Porto

08036

Clinic Barcelona Hospital Universitari, Barcelona

BA1 3NG

Royal United Hospital, Bath

W1G 6AD

Sarah Cannon Research Institute UK, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

HA62RN

The East and North Hertfordshire NHS Trust, Middlesex

S10 2SJ

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield South Yorkshire

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) | Biotech Hunter | Biotech Hunter