A Phase II Study of Neoadjuvant Trastuzumab+Docetaxel+NPLD+/-Bevacizumab in Her2-pos. Early Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab, Docetaxel

"6 cycles - Day1 (Day22 = Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.~Docetaxel: 100 mg/m2 by 60 min i.v. infusion"

DRUG

Trastuzumab, Docetaxel, Bevacizumab

"6 cycles - Day1 (Day22 = Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.~Docetaxel: 100 mg/m2 by 60 min i.v. infusion Bevacizumab 15 mg/kg"

DRUG

Trastuzumab+Docetaxel+NPLD

"6 cycles - Day1 (Day22=Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.~Docetaxel: 75 mg/m2 by 60 min IV infusion NPLD 50 mg/m2 by 60 min i.v. infusion"

DRUG

Trastuzumab+Docetaxel+NPLD+Bevacizumab

"6 cycles - Day1 (Day22= Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.~Docetaxel: 75 mg/m2 by 60 min i.v. infusion NPLD: 50 mg/m2 by 60 min i.v. infusion; Bevacizumab 15 mg/kg"

Trial Locations (11)

1090

Med. Univ. Vienna; General Hospital Vienna, Vienna

Medical University Vienna, General Hospital, Vienna

1130

State Hospital Vienna-Hietzing, Vienna

4010

Hospital BHS Linz, Coop. Study Group, Linz

4020

AKH Linz, Linz

5020

Paracelsus Medical University Salzburg-Oncology, Coop. Group, Salzburg

6020

Gynaegological Medical University Innsbruck, Innsbruck

6330

District Hospital Kufstein, Kufstein

6807

State Hospital Feldkirch, Coop. Group, Feldkirch

8036

Medical University of Graz-Oncology; Coop. Group, Graz

8700

State Hospital Leoben, Leoben

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Cephalon

INDUSTRY

lead

Austrian Breast & Colorectal Cancer Study Group

NETWORK