Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

Doxorubicin and cyclophosphamide (AC) + bevacizumab

"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* doxorubicin 60 mg/m\^2 IV push or infusion followed by cyclophosphamide 600 mg/m\^2 IV push or infusion~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"

DRUG

Docetaxel (T) + bevacizumab

"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* docetaxel 100 mg/m\^2 IV~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy~Note: The starting dose of docetaxel was reduced to 75 mg/m\^2 if toxicity occurred that met the criteria for doxorubicin dose reduction"

DRUG

Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab

"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* doxorubicin 50 mg/m\^2 IV push or infusion followed by cyclophosphamide 500 mg/m\^2 IV push or infusion followed by docetaxel 75 mg/m\^2~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"

DRUG

Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab

"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* docetaxel in 75 mg/m\^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by~* trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2)~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"

DRUG

Bevacizumab and trastuzumab maintenance therapy

"* bevacizumab 15 mg/kg was infused IV followed by~* trastuzumab 6 mg/kg IV~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."

DRUG

Bevacizumab maintenance therapy

"\- bevacizumab 15 mg/kg was infused IV~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."

Trial Locations (1)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY