A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00846027
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab was supplied as a sterile liquid in glass vials.
  • Paclitaxel — DRUG
    Paclitaxel was supplied as a sterile liquid in glass vials.
  • Gemcitabine — DRUG
    Gemcitabine was supplied as a sterile liquid in glass vials.

Study Details

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m\^2 iv, and gemcitabine 200 mg/m\^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

Key Dates

First listed
Feb 18, 2009
Start date
Jan 31, 2009
Status verified
Jul 2014
Primary completion
Dec 31, 2011
Completion
Jan 31, 2013

Study Design

Enrollment
90 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + paclitaxel + gemcitabine
    Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ]

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