Clinical trial NCT00364611
Conditions: Breast Cancer
Sponsor: Sanofi
Start date: 2006-08-01; Completion date: 2012-04-01
Enrollment: 73 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).

All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.

Detailed description:
The study included:

* Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing informed consent
* Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity, had disease progression, withdrew consent, or died
* If participants experienced a complete response (CR), partial response (PR), or stable disease (SD) at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel, they could continue on bevacizumab and/or trastuzumab until they developed unacceptable toxicity, had disease progression, or withdrew consent
* Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death

Arms: arm 1: Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met arm 2: Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Interventions: intervention 1: Bevacizumab intervention 2: Docetaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: 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 intervention 2: Docetaxel 75 mg/m\^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w intervention 3: * 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

Protocol documents: