Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

Sponsor
Chugai Pharmaceutical
Study ID
NCT00467012
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    10mg/kg，Day1, 15 of 1 cycle(4 weeks)
  • Paclitaxel — DRUG
    90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)

Study Details

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

Key Dates

First listed
Apr 27, 2007
Start date
Apr 30, 2007
Status verified
Apr 2012
Primary completion
Jun 30, 2009
Completion
Sep 30, 2011

Study Design

Enrollment
122 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: step 1
    6 enrollment for 1 cycle(4 weeks)
  • Experimental: step 2
    114 enrollment through to meet the stopping criteria

Primary Outcome Measure

Safety [ Time Frame: throughout study ]

Related Studies