Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
1 other identifier
interventional
83
1 country
31
Brief Summary
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2007
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 9, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
July 22, 2011
CompletedJuly 25, 2011
July 1, 2011
2.8 years
May 7, 2007
June 23, 2011
July 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Objective Response
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Baseline, Week 9, and every 8 weeks up to Month 34
Secondary Outcomes (18)
Number of Participants With Clinical Benefit
Baseline, Week 9, and every 8 weeks up to Month 34
Number of Participants With Objective Response of Superficial Lesions
Baseline, every 4 weeks up to Month 34
Progression-Free Survival (PFS)
Baseline up to Month 34
Duration of Response (DR)
Baseline up to Month 34 or early termination
Overall Survival (OS)
Baseline until death (up to Month 34)
- +13 more secondary outcomes
Other Outcomes (1)
1-Year Survival Probability
Baseline up to 1 year
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inflammatory breast cancer
- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (31)
Pfizer Investigational Site
Bakersfield, California, 93309, United States
Pfizer Investigational Site
Burbank, California, 91505-4866, United States
Pfizer Investigational Site
Fountain Valley, California, 92708, United States
Pfizer Investigational Site
Hawthorne, California, 90250, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Boynton Beach, Florida, 33435, United States
Pfizer Investigational Site
Zion, Illinois, 60099, United States
Pfizer Investigational Site
Louisville, Kentucky, 40207, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49007, United States
Pfizer Investigational Site
Maple Grove, Minnesota, 55369, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55454, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55455, United States
Pfizer Investigational Site
Columbia, Missouri, 65203, United States
Pfizer Investigational Site
Asheville, North Carolina, 28806, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599, United States
Pfizer Investigational Site
Kernersville, North Carolina, 27284, United States
Pfizer Investigational Site
Lexington, North Carolina, 27292, United States
Pfizer Investigational Site
North Wilkesboro, North Carolina, 28659, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Bismarck, North Dakota, 58501, United States
Pfizer Investigational Site
Franklin, Tennessee, 37067, United States
Pfizer Investigational Site
Gallatin, Tennessee, 37066, United States
Pfizer Investigational Site
Hermitage, Tennessee, 37076, United States
Pfizer Investigational Site
Lebanon, Tennessee, 37087, United States
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Nashville, Tennessee, 37205, United States
Pfizer Investigational Site
Nashville, Tennessee, 37207, United States
Pfizer Investigational Site
Nashville, Tennessee, 37211, United States
Pfizer Investigational Site
Smyrna, Tennessee, 37167, United States
Pfizer Investigational Site
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 9, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 25, 2011
Results First Posted
July 22, 2011
Record last verified: 2011-07