Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

725

Participants

Timeline

Start Date

April 29, 2013

Primary Completion Date

May 5, 2016

Study Completion Date

January 27, 2017

Conditions
Breast Cancer
Interventions
DRUG

ABP 980

ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.

DRUG

Trastuzumab

Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.

DRUG

Paclitaxel

Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).

PROCEDURE

Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection

Trial Locations (98)

1083

Research Site, Budapest

1122

Research Site, Budapest

1756

Research Site, Sofia

2193

Research Site, Johannesburg

4032

Research Site, Debrecen

4091

Research Site, Durban

4400

Research Site, Nyíregyháza

5000

Research Site, Veliko Tarnovo

Research Site, Szolnok

5800

Research Site, Pleven

7100

Research Site, Szekszárd

7405

Research Site, Cape Town

7700

Research Site, Cape Town

9010

Research Site, Varna

11000

Research Site, Belgrade

11080

Research Site, Belgrade

11527

Research Site, Athens

12462

Research Site, Athens

13353

Research Site, Berlin

15009

Research Site, A Coruña

15517

Research Site, Fürstenwalde

18000

Research Site, Niš

20141

Research Site, Milan

21100

Research Site, Varese

21204

Research Site, Kamenitz

22040

Research Site, San Fermo della Battaglia

25198

Research Site, Lleida

28050

Research Site, Madrid

28220

Research Site, Madrid

28921

Research Site, Alcorcón

29100

Research Site, Piacenza

34000

Research Site, Kragujevac

43018

Research Site, Lutsk

43100

Research Site, Parma

46236

Research Site, Bottrop

49055

Research Site, Dnipropetrovsk

50180

Research Site, Toluca, Estado de Mexico

53111

Research Site, Bonn

56429

Research Site, Thessaloniki

58013

Research Site, Chernivtsi

60389

Research Site, Frankfurt am Main

60590

Research Site, Frankfurt am Main

61070

Research Site, Kharkiv

64710

Research Site, Monterrey

69040

Research Site, Zaporizhzhya

71110

Research Site, Heraklion

74124

Research Site, Bari

76090

Research Site, Querétaro

78200

Research Site, San Luis Potosí City

79031

Research Site, Lviv

88000

Research Site, Uzhhorod

90127

Research Site, Palermo

100337

Research Site, Ploieşti

115478

Research Site, Moscow

143423

Research Site, Moscow Region

150054

Research Site, Yaroslavl

163045

Research Site, Arkhangelsk

195271

Research Site, Saint Petersburg

197089

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

220013

Research Site, Minsk

223040

Research Site, Minsk

224027

Research Site, Brest

230017

Research Site, Grodno

249036

Research Site, Obninsk

300595

Research Site, Timișoara

354057

Research Site, Sochi

357502

Research Site, Pyatigorsk

390011

Research Site, Ryazan

400006

Research Site, Cluj-Napoca

400058

Research Site, Cluj-Napoca

430032

Research Site, Saransk

454087

Research Site, Chelaybinsk

500091

Research Site, Brasov

603081

Research Site, Nizhny Novgorod

4810469

Research Site, Temuco

8360160

Research Site, Santiago

41820-021

Research Site, Salvador

98700-000

Research Site, Ijuí

91350-200

Research Site, Porto Alegre

17210-080

Research Site, Jaú

09060-650

Research Site, Santo André

04039-004

Research Site, São Paulo

E1C6Z8

Research Site, Moncton

H1T 2M4

Research Site, Montreal

60-569

Research Site, Poznan

61-485

Research Site, Poznan

85-792

Research Site, Bydgoszcz

20-090

Research Site, Warszawa

02-776

Research Site, Warsaw

03-291

Research Site, Warsaw

80-219

Research Site, Gdansk

44-217

Research Site, Rybnik

08208

Research Site, Sabadell

08041

Research Site, Barcelona

03115

Research Site, Kyiv

NG5 1PB

Research Site, Nottingham

PE3 9GZ

Research Site, Peterborough

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Actavis Inc.

INDUSTRY

lead

Amgen

INDUSTRY

NCT01901146 - Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer | Biotech Hunter | Biotech Hunter