A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)

Sponsor
Genentech, Inc.
Study ID
NCT00434356
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    Intravenous repeating dose
  • sunitinib — DRUG
    Oral repeating dose
  • paclitaxel — DRUG
    Intravenous repeating dose

Study Details

This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.

Key Dates

First listed
Feb 13, 2007
Start date
Mar 31, 2007
Status verified
Nov 2009
Primary completion
May 31, 2008

Study Design

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

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

Best Response [ Time Frame: From randomization until disease progression/recurrence (by patient) ]

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