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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

Phase 3
18 Years
Not Enrolling
Breast Neoplasms

Thank you

Trial Information

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

On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of
Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria
and was unlikely to meet its primary endpoint to demonstrate a statistically significant
improvement in progression-free survival (PFS) in patients treated with sunitinib plus
paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators
involved in the study and regulatory agencies of these findings. Enrollment in this study
has been stopped.

Inclusion Criteria:

- Diagnosis of advanced breast cancer.

- Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or
bone-only disease.

- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

- No prior treatment with cytotoxics in the advanced disease setting.

- HER2/neu positive disease unless trastuzumab was previously received or is

- Treatment with a taxane in the adjuvant setting unless disease free interval >12
months after end of treatment.

Type of Study:


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:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

August 2011

Related Keywords:

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



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