A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

July 29, 2015

Primary Completion Date

February 20, 2019

Study Completion Date

March 23, 2020

Conditions
Metastatic Breast Cancer
Interventions
DRUG

paclitaxel

paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15)

DRUG

Reparixin

reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle

DRUG

placebo

placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle

Trial Locations (77)

1200

Cliniques Universitaires Saint- LUC UCL, Brussels

2650

Universitair Ziekenhuis Antwerpen, Edegem

2930

Algemeen Ziekenhuis Klina, Brasschaat

5000

AZ St Elisabeth, Namur

7000

CHU Ambroise Paré, Mons

10034

Fakultní nemocnice Královské Vinohrady, Prague

12808

Onkologická klinika VFN a 1.LF UK, Prague

13009

Institut Paoli Calmettes, Marseille

14000

Centre François Baclesse, Caen

15001

Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie, Bialystok

15006

Fakultní nemocnice v Motole, Onkologická klinika 2. LF UK a FN Motol, Prague

Complejo Hospitalario Universitario La Coruña, A Coruña

15009

Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica, A Coruña

18512

Hematology and Oncology Associates of Northeast PA, Dunmore

19107

Thomas Jefferson University, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20090

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Lublin

20141

Istituto Europeo di Oncologia, Milan

20153

Azienda Ospedaliera, Ospedale San Carlo Borromeo, Milan

26831

Nemocnice Horovice a.s., Hořovice

27100

Fondazione IRCCS Policlinico S. Matteo, Pavia

27518

Waverly Hematology Oncology, Cary

28007

Hospital General Universitario Gregorio Marañon, Madrid

28050

Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid

30005

Atlanta Cancer Care, Alpharetta

30033

Atlanta Cancer Care, Decatur

Northside Hospital, Inc.-Georgia Cancer Specialists, Decatur

30041

Atlanta Cancer Care, Cumming

30060

Northside Hospital, Inc.-Georgia Cancer Specialists, Marietta

30094

Atlanta Cancer Care, Conyers

30114

Northside Hospital, Inc.-Georgia Cancer Specialists, Canton

30122

Ospedale SS Giovanni e Paolo, Venezia

30174

Ospedale dell'Angelo, Mestre

30236

Atlanta Cancer Care, Jonesboro

30265

Southeastern Regional Medical Center, Newnan

30342

Atlanta Cancer Care, Atlanta

Northside Hospital, Inc., Atlanta

Northside Hospital, Inc.-Georgia Cancer Specialists, Sandy Springs

30606

Northside Hospital, Inc.-Georgia Cancer Specialists, Athens

31217

Northside Hospital, Inc.-Georgia Cancer Specialists, Macon

32117

Florida Cancer Specialists, Daytona Beach

33100

Azienda Opspedaliero Universitaria Santa Maria della Misericordia, Udine

33401

Florida Cancer Specialists, West Palm Beach

35085

Mrukmed. Lekarz Beata Madej Mruk i Partner. Spólka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów

36204

C. Hospital Xeral-Cies, Vigo

36608

Southern Cancer Center, Mobile

37404

Tennessee Oncology PLLC, Chattanooga

44805

Medicale Centre René Gauducheau, Saint-Herblain

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48109

University of Michigan Cancer Center, Ann Arbor

49000

Centre Paul Papin, Angers

50005

Fakultni nemocnice Hradec Králové, Hradec Králové

54915

Fox Valley Hematology and Oncology, SC, Appleton

59100

Nuovo Ospedale, Prato

60625

Swedish Covenant, Chicago

61122

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro

61701

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu, Poznan

61761

Mid Illinois Hematology & Oncology Associates, Ltd., Normal

65653

Masaryk Memorial Cancer Institute, Brno

72100

"Ospedale Di Summa-Perrino", Brindisi

75015

Hôpital Européen Georges Pompidou, Paris

76275

Krajská nemocnice T.Bati, a. s., Zlín

77030

MD Anderson Cancer Center, Houston

The Methodist Hospital, Houston

80219

Wojewódzkie Centrum Onkologii, Gdansk

85925

Centre hospitalier de Saint-Brieuc, Yves Le Foll, La Roche-sur-Yon

87000

Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren, Limoges

93309

CBCC Global Research a Comprehensive Blood and Cancer Center, Bakersfield

95123

Azienda Ospedaliero - Universitaria, Policlinico Vittorio Emanuele, Catania

98004

Overlake Medical Center, Bellevue

07960

Summit Medical Group, Morristown

07871

Regional Cancer Care Associates, Sparta

06100

Centre Antoine Lacassagne, Nice

09042

Azienda Ospedaliero-Universitaria, Cagliari

04125

Magodent Sp. z o. o., Warsaw

08003

Hospital del Mar, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

Dompé Farmaceutici S.p.A

INDUSTRY