Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

June 30, 2011

Study Completion Date

April 30, 2012

Conditions
Breast Cancer
Interventions
DRUG

Bevacizumab

"Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on~* On Day 1 of the 1st cycle over 120 minutes~* On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose~* On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses~* On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses"

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w

DRUG

Trastuzumab

"* A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1.~* For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion"

Trial Locations (1)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT00364611 - Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter