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A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bessemer, Alabama, 35022 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00373256
Pfizer
Completed
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

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A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
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
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Sunitinib
    Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
    Other Name: SU011248, Sutent
  • Drug: paclitaxel
    Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
  • Drug: bevacizumab
    Bevacizumab 10 mg/kg IV every 2 weeks.
    Other Name: Avastin
  • Experimental: A
    Interventions:
    • Drug: Sunitinib
    • Drug: paclitaxel
  • Active Comparator: B
    Interventions:
    • Drug: bevacizumab
    • Drug: paclitaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
August 2011
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Spain,   United States
Puerto Rico
 
NCT00373256
A6181094
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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