Clinical trial NCT00365365
Conditions: Breast Cancer
Sponsor: Sanofi
Start date: 2006-08-01; Completion date: 2011-10-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.

Detailed description:
In this study, participants were stratified according to HER2 status at the time of enrollment. HER2-negative participants were randomized in a 1:1 ratio to either stratum 1 (AC-\>T sequential + bevacizumab) or stratum 2 (TAC + bevacizumab). All HER2-positive participants were assigned to stratum 3 (TCH + bevacizumab).

The study included a treatment period of 1 year, followed by a 2 year posttreatment survival follow-up period.

Arms: arm 1: HER2-negative participants administered

* doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
* docetaxel (T) + bevacizumab for 4 cycles followed by
* bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed arm 2: HER2-negative participants administered

* docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
* bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed arm 3: All HER2-positive participants administered

* docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
* bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed
Interventions: intervention 1: Doxorubicin and cyclophosphamide (AC) + bevacizumab intervention 2: Docetaxel (T) + bevacizumab intervention 3: Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab intervention 4: Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab intervention 5: Bevacizumab and trastuzumab maintenance therapy intervention 6: Bevacizumab maintenance therapy
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: 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 intervention 4: 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 intervention 5: * 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. intervention 6: \- 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.

Protocol documents: