A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

June 30, 2011

Conditions
Breast Neoplasms
Interventions
DRUG

Sunitinib + Capecitabine

"Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.~Capecitabine administered orally at a starting dose of 2000 mg/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons."

DRUG

Capecitabine

Capecitabine administered orally at a starting dose of 2500 mg/m\^2 per day \[1250 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

Trial Locations (169)

4

Pfizer Investigational Site, Dublin

7

Pfizer Investigational Site, Dublin

8

Pfizer Investigational Site, Dublin

2100

Pfizer Investigational Site, Koebenhavn OE

2300

Pfizer Investigational Site, Turnhout

3000

Pfizer Investigational Site, Leuven

4000

Pfizer Investigational Site, Liège

4010

Pfizer Investigational Site, Linz

5000

Pfizer Investigational Site, Namur

Pfizer Investigational Site, Odense

5530

Pfizer Investigational Site, Yvoir

7600

Pfizer Investigational Site, Levanger

9100

Pfizer Investigational Site, Aalborg

10126

Pfizer Investigational Site, Torino

11009

Pfizer Investigational Site, Cadiz

14076

Pfizer Investigational Site, Caen

15006

Pfizer Investigational Site, Prague

15009

Pfizer Investigational Site, A Coruña

15025

Pfizer Investigational Site, Clairton

15090

Pfizer Investigational Site, Wexford

15213

Pfizer Investigational Site, Pittsburgh

15232

Pfizer Investigational Site, Pittsburgh

15517

Pfizer Investigational Site, Fürstenwalde

15601

Pfizer Investigational Site, Greensburg

18547

Pfizer Investigational Site, Athens

19464

Pfizer Investigational Site, Pottstown

20148

Pfizer Investigational Site, Milan

20850

Pfizer Investigational Site, Rockville

20895

Pfizer Investigational Site, Kensington

21047

Pfizer Investigational Site, Saronno (VA)

23235

Pfizer Investigational Site, Richmond

25123

Pfizer Investigational Site, Brescia

26500

Pfizer Investigational Site, Pátrai

28034

Pfizer Investigational Site, Madrid

28046

Pfizer Investigational Site, Madrid

28203

Pfizer Investigational Site, Charlotte

28204

Pfizer Investigational Site, Charlotte

28211

Pfizer Investigational Site, Charlotte

28262

Pfizer Investigational Site, Charlotte

28277

Pfizer Investigational Site, Charlotte

30045

Pfizer Investigational Site, Lawrenceville

30078

Pfizer Investigational Site, Snellville

30096

Pfizer Investigational Site, Duluth

33021

Pfizer Investigational Site, Hollywood

33028

Pfizer Investigational Site, Pembroke Pines

33065

Pfizer Investigational Site, Coral Springs

33076

Pfizer Investigational Site, Bordeaux

33125

Pfizer Investigational Site, Miami

33129

Pfizer Investigational Site, Miami

33133

Pfizer Investigational Site, Miami

33428

Pfizer Investigational Site, Boca Raton

33437

Pfizer Investigational Site, Boynton Beach

33467

Pfizer Investigational Site, Lake Worth

33805

Pfizer Investigational Site, Lakeland

34059

Pfizer Investigational Site, Montpellier

37066

Pfizer Investigational Site, Gallatin

37067

Pfizer Investigational Site, Franklin

37076

Pfizer Investigational Site, Hermitage

37087

Pfizer Investigational Site, Lebanon

37099

Pfizer Investigational Site, Göttingen

37130

Pfizer Investigational Site, Murfreesboro

37167

Pfizer Investigational Site, Smyrna

37203

Pfizer Investigational Site, Nashville

37205

Pfizer Investigational Site, Nashville

37207

Pfizer Investigational Site, Nashville

37211

Pfizer Investigational Site, Nashville

38120

Pfizer Investigational Site, Memphis

38834

Pfizer Investigational Site, Corinth

39576

Pfizer Investigational Site, Stendal

40138

Pfizer Investigational Site, Bologna

41020

Pfizer Investigational Site, Seville

43100

Pfizer Investigational Site, Parma

46123

Pfizer Investigational Site, Avon

46158

Pfizer Investigational Site, Mooresville

46260

Pfizer Investigational Site, Indianapolis

48149

Pfizer Investigational Site, Münster

49033

Pfizer Investigational Site, Angers

54100

Pfizer Investigational Site, Nancy

59101

Pfizer Investigational Site, Billings

60590

Pfizer Investigational Site, Frankfurt am Main

65201

Pfizer Investigational Site, Columbia

66333

Pfizer Investigational Site, Völklingen

67227

Pfizer Investigational Site, Frankenthal

70002

Pfizer Investigational Site, Metairie

70006

Pfizer Investigational Site, Metairie

70056

Pfizer Investigational Site, Gretna

70072

Pfizer Investigational Site, Marrero

70115

Pfizer Investigational Site, New Orleans

70433

Pfizer Investigational Site, Covington

71103

Pfizer Investigational Site, Shreveport

73071

Pfizer Investigational Site, Norman

73120

Pfizer Investigational Site, Oklahoma City

74104

Pfizer Investigational Site, Tulsa

74133

Pfizer Investigational Site, Tulsa

74136

Pfizer Investigational Site, Tulsa

75231

Pfizer Investigational Site, Paris

77701

Pfizer Investigational Site, Beaumont

78405

Pfizer Investigational Site, Corpus Christi

78410

Pfizer Investigational Site, Corpus Christi

78626

Pfizer Investigational Site, Georgetown

78705

Pfizer Investigational Site, Austin

78745

Pfizer Investigational Site, Austin

78757

Pfizer Investigational Site, Austin

78759

Pfizer Investigational Site, Austin

84010

Pfizer Investigational Site, Bountiful

84041

Pfizer Investigational Site, Layton

84102

Pfizer Investigational Site, Salt Lake City

84106

Pfizer Investigational Site, Salt Lake City

84120

Pfizer Investigational Site, West Valley City

84157

Pfizer Investigational Site, Murray

84604

Pfizer Investigational Site, West Provo

87106

Pfizer Investigational Site, Albuquerque

87109

Pfizer Investigational Site, Albuquerque

89075

Pfizer Investigational Site, Ulm

90127

Pfizer Investigational Site, Palermo

90241

Pfizer Investigational Site, Downey

90419

Pfizer Investigational Site, Nuremberg

90606

Pfizer Investigational Site, Whittier

90640

Pfizer Investigational Site, Montebello

91054

Pfizer Investigational Site, Erlangen

93720

Pfizer Investigational Site, Fresno

98122

Pfizer Investigational Site, Messina

99336

Pfizer Investigational Site, Kennewick

143423

Pfizer Investigational Site, Moscow

188663

Pfizer Investigational Site, Kuzmolovo, Vsevolozhsk District

191104

Pfizer Investigational Site, Saint Petersburg

197758

Pfizer Investigational Site, Saint Petersburg

400015

Pfizer Investigational Site, Cluj-Napoca

23298-0037

Pfizer Investigational Site, Richmond

A-5020

Pfizer Investigational Site, Salzburg

A-4600

Pfizer Investigational Site, Wels

T2N 4N2

Pfizer Investigational Site, Calgary

T2S 3C3

Pfizer Investigational Site, Calgary

L1G 2B9

Pfizer Investigational Site, Oshawa

H2W 1T8

Pfizer Investigational Site, Montreal

H3A 1A1

Pfizer Investigational Site, Montreal

H3G 1A4

Pfizer Investigational Site, Montreal

H3T 1E2

Pfizer Investigational Site, Montreal

H3T 1M5

Pfizer Investigational Site, Montreal

140 59

Pfizer Investigational Site, Prague

150 06

Pfizer Investigational Site, Prague

Cedex 08

Pfizer Investigational Site, Lyon

71 110

Pfizer Investigational Site, Heraklion

45 110

Pfizer Investigational Site, Ioannina

564 03

Pfizer Investigational Site, Thessaloniki

00133

Pfizer Investigational Site, Roma

00144

Pfizer Investigational Site, Roma

1081 HV

Pfizer Investigational Site, Amsterdam

6162 BG

Pfizer Investigational Site, Sittard-geleen

8025 AB

Pfizer Investigational Site, Zwolle

0407

Pfizer Investigational Site, Oslo

93-509

Pfizer Investigational Site, Lodz

20-090

Pfizer Investigational Site, Lublin

00-909

Pfizer Investigational Site, Warsaw

02-781

Pfizer Investigational Site, Warsaw

022328

Pfizer Investigational Site, Bucharest

08036

Pfizer Investigational Site, Barcelona

09005

Pfizer Investigational Site, Burgos

TR1 3LJ

Pfizer Investigational Site, Truro

Pfizer Investigational Site, Truro

CM1 7WE

Pfizer Investigational Site, Chelmsford

CM20 1QX

Pfizer Investigational Site, Harlow

DE13 0RB

Pfizer Investigational Site, Burton-on-Trent

BN11 2DH

Pfizer Investigational Site, Worthing

Pfizer Investigational Site, Worthing

B15 2TH

Pfizer Investigational Site, Birmingham

CM16 6TN

Pfizer Investigational Site, Essex

W6 8RF

Pfizer Investigational Site, London

SA2 8QA

Pfizer Investigational Site, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00435409 - A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer | Biotech Hunter | Biotech Hunter