A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Breast Cancer
Interventions
DRUG

Pertuzumab

Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle.

DRUG

Trastuzumab

Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle.

DRUG

Vinorelbine

A dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle.

Trial Locations (80)

2100

København Ø

2730

Herlev

5000

Odense

7400

Herning

14076

Caen

16132

Genoa

20357

Hamburg

20900

Monza

22190

Plérin

22300

Barbastro

22408

Fredericksburg

24000

Périgueux

26100

Cremona

26789

Leer

27710

Durham

28223

Madrid

29010

Málaga

30060

Marietta

33006

Oviedo

33021

Hollywood

33081

Aviano

33136

Miami

33324

Plantation

33332

Gütersloh

34119

Kassel

37024

Negrar

37044

Tours

38320

San Cristóbal de La Laguna

38642

Goslar

38700

La Tronche

39008

Santander

40024

Mont-de-Marsan

40138

Bologna

43210

Columbus

44263

Dortmund

46014

Valencia

47441

Moers

49124

Georgsmarienhütte

50677

Cologne

52146

Würselen

55043

Lido di Camaiore

56100

Pisa

60389

Frankfurt am Main

66822

Lebach

67065

Strasbourg

67655

Kaiserslautern

69115

Heidelberg

69495

Pierre-Bénite

75651

Paris

75908

Paris

76038

Rouen

77090

Houston

78229

San Antonio

79110

Freiburg im Breisgau

80220

Denver

80335

München

80639

München

84082

Avignon

84403

Ogden

85724

Tucson

88212

Ravensburg

92318

Neumarkt

93009

Bobigny

94805

Villejuif

98101

Seattle

98195

Seattle

94305-5151

Stanford

02215

Boston

07960

Morristown

20560-120

Rio de Janeiro

14784-400

Barretos

01308-050

São Paulo

01317-000

São Paulo

04039-901

São Paulo

01307

Dresden

00189

Rome

05100

Terni

06080

Badajoz

07198

Palma de Mallorca

08227

Terrassa

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01565083 - A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer | Biotech Hunter | Biotech Hunter