2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab

Sponsor
Central European Cooperative Oncology Group
Study ID
NCT00600340
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab and Paclitaxel — BIOLOGICAL
    A: Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
  • Bevacizumab and Capecitabine — BIOLOGICAL
    B:Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks

Study Details

First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.

Key Dates

First listed
Jan 25, 2008
Start date
Apr 30, 2008
Status verified
Oct 2019
Primary completion
Sep 30, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Active Comparator: A Bev+Pac
    Bevacizumab plus Paclitaxel
  • Active Comparator: B Bev+Cap
    Bevacizumab plus Capecitabine

Primary Outcome Measure

Overall Survival (PP Population) [ Time Frame: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years ]

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