Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

NCT00471276

Last updated date
Study Location
Pfizer Investigational Site
Bakersfield, California, 93309, United States
Contact
1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
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

- Histologically or cytologically proven diagnosis of breast cancer

- Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy

- Patients with at least one measurable lesion as per RECIST

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


- Inflammatory breast cancer


- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months
ago)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
Official Title  ICMJE A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
Brief Summary Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: sunitinib
sunitinib (Sutent), 37.5 mg, daily dosing
Other Name: Sutent, sunitinib
Study Arms  ICMJE Experimental: 1
Intervention: Drug: sunitinib
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: May 12, 2009)
83
Original Enrollment  ICMJE
 (submitted: May 7, 2007)
88
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of breast cancer
  • Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
  • Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

  • Inflammatory breast cancer
  • Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471276
Other Study ID Numbers  ICMJE A6181068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2011

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