Status:
COMPLETED
Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally once daily in patients with Metastatic Breast Cancer
Eligibility Criteria
Inclusion
- Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
- Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease.
Exclusion
- Prior treatment with \>/= 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes
- Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00322517
Start Date
April 1 2006
End Date
July 1 2009
Last Update
May 17 2011
Active Locations (22)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90095
2
Pfizer Investigational Site
Pasadena, California, United States, 91105
3
Pfizer Investigational Site
Santa Monica, California, United States, 90404
4
Pfizer Investigational Site
Valancia, California, United States, 91355