Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Breast Neoplasms
Interventions
DRUG

Docetaxel

"75 mg/m\^2 administered IV on Day 1 for Cycles 1-6~All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg)."

DRUG

Doxorubicin

50 mg/m\^2 administered IV on Day 1 for Cycles 1-6

DRUG

Carboplatin

6 mg/mL/min (target area under the curve \[AUC\] dose) administered IV on Day 1 for Cycles 1-6

DRUG

Cyclophosphamide

500 mg/m\^2 administered IV on Day 1 for Cycles 1-6

DRUG

Trastuzumab

A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy

DRUG

Bevacizumab

15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy

Trial Locations (1)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY