Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

Key facts

Study ID

NCT00243503

Run by

Pfizer

People needed

60

Starts

2006-02-01

Expected to finish

2010-07-01

Last updated by the study team

2011-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
• HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
• Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

You may not qualify if…

• Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
• Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
• Prior treatment on a SU11248 clinical trial.
• Uncontrolled brain metastases.

Where it is running

• Pfizer Investigational Site — Montgomery, Alabama, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Wilmington, Delaware, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Harvey, Illinois, United States
• Pfizer Investigational Site — Tinley Park, Illinois, United States
• Pfizer Investigational Site — Munster, Indiana, United States
• Pfizer Investigational Site — Lafayette, Louisiana, United States
• Pfizer Investigational Site — New Iberia, Louisiana, United States
• Pfizer Investigational Site — Corinth, Mississippi, United States
• Pfizer Investigational Site — Southaven, Mississippi, United States
• Pfizer Investigational Site — Las Vegas, Nevada, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Memphis, Tennessee, United States
• Pfizer Investigational Site — Memphis, Tennessee, United States
• Pfizer Investigational Site — Ottignies, Belgium
• Pfizer Investigational Site — Wilrijk, Belgium
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Greenfield Park, Quebec, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Besançon, France
• Pfizer Investigational Site — Lyon, France
• Pfizer Investigational Site — Saint-Cloud, France
• Pfizer Investigational Site — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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