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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
N/A
Not Enrolling
Both
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
contraindicated.

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

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

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteMorgantown, West Virginia  26506