Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

March 9, 2009

Primary Completion Date

February 27, 2014

Study Completion Date

October 19, 2015

Conditions
Breast CancerBreast NeoplasmsBreast TumorsCancerLocally Recurrent and Metastatic Breast CancerMetastasesMetastatic CancerOncologySolid TumorsTumors
Interventions
DRUG

AMG 386 30 mg/kg, Paclitaxel and Trastuzumab

AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W

DRUG

AMG 386 30 mg/kg, Capecitabine and Lapatinib

AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD

DRUG

AMG 386 10 mgkg, Paclitaxel and Trastuzumab

AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W

DRUG

AMG 386 10 mg/kg, Capecitabine and Lapatinib

AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD

Trial Locations (23)

2610

Research Site, Wilrijk

3000

Research Site, Leuven

4000

Research Site, Liège

10032

Research Site, New York

10956

Research Site, New City

10960

Research Site, Nyack

11021

Research Site, Great Neck

13009

Research Site, Marseille

14076

Research Site, Caen

31052

Research Site, Toulouse

33075

Research Site, Bordeaux

33428

Research Site, Boca Raton

44202

Research Site, Nantes

45042

Research Site, Middletown

52242

Research Site, Iowa City

55407

Research Site, Minneapolis

69495

Research Site, Pierre Bénite Cedex

85724

Research Site, Tucson

85925

Research Site, La Roche-sur-Yon

87131

Research Site, Albuquerque

02111

Research Site, Boston

03756-0001

Research Site, Lebanon

03756

Research Site, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY