A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00333775
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
  • Placebo to bevacizumab — DRUG
    Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
  • Bevacizumab — DRUG
    Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Study Details

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Key Dates

First listed
Jun 6, 2006
Start date
Mar 31, 2006
Status verified
Dec 2015
Primary completion
Oct 31, 2007
Completion
Oct 31, 2013

Study Design

Enrollment
736 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel 100 mg/m^2 plus placebo
    Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
  • Experimental: Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg
    Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
  • Experimental: Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg
    Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ]

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