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

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NCT00373256

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Study Location
Pfizer Investigational Site
Bessemer, Alabama, 35022, United States
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Contact
1-800-718-1021
[email protected]izer.com
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Official Title  ICMJE 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
Brief Summary To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: Sunitinib
    • Drug: paclitaxel
  • Active Comparator: B
    Interventions:
    • Drug: bevacizumab
    • Drug: paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2012)		488
Original Enrollment  ICMJE
 (submitted: September 7, 2006)		740
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00373256
Other Study ID Numbers  ICMJE A6181094
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP