Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

Sponsor
iOMEDICO AG
Study ID
NCT00868634
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • capecitabine — DRUG
    1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
  • bevacizumab — DRUG
    15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
  • capecitabine — DRUG
    1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
  • bevacizumab — DRUG
    15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
  • vinorelbine — DRUG
    25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.

Study Details

The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.

Key Dates

Start date
Feb 28, 2009
Status verified
Aug 2016
Primary completion
Mar 31, 2014
Completion
Oct 31, 2015

Study Design

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

Arms

  • Active Comparator: A
    Capecitabine / Bevacizumab
  • Experimental: B
    Capecitabine / Bevacizumab / Vinorelbine

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: end of trial ]

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