A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4

Outcome Time Frame:

From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181094

NCT ID:

NCT00373256

Start Date:

November 2006

Completion Date:

August 2011

Related Keywords:

• Breast Neoplasms
• Breast cancer
• advanced
• sunitinib
• bevacizumab
• paclitaxel
• Phase 3
• Breast Neoplasms
• Neoplasms