EUCTR2005-003773-25-BE
Active, not recruiting
Not Applicable
A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN COMBINATION WITH TRASTUZUMAB AS TREATMENT FOR METASTATIC DISEASE IN PATIENTS WITH BREAST CANCER
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- locally recurrent or metastatic BC
- Sponsor
- PFIZER s.a.
- Enrollment
- 128
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically or cytologically proven diagnosis of breast cancer with evidence of
- •1\) unresectable, locally recurrent, or 2\) metastatic disease. Locally recurrent
- •disease must not be amenable to resection or radiation therapy with curative
- •2\. Measurable disease as per Response Evaluation Criteria in Solid Tumors
- •(RECIST). Measurable lesions that have been previously radiated will not be
- •considered target lesions unless an increase in size is observed following
- •completion of radiation therapy.
- •3\. HER2 positive disease (3\+ by immunohistochemistry \[IHC] or FISH\-positive)
- •4\. Candidate for treatment with trastuzumab. Prior treatment with trastuzumab
- •and/or lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is
Exclusion Criteria
- •1\. Exclusion criterion 1 deleted by Protocol Amendment 2\.
- •2\. Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease
- •setting therapy is permitted. A regimen is defined as treatment until progression,
- •regardless of therapies included in that regimen prior to progression.
- •3\. Exclusion criterion 3 deleted by Protocol Amendment 2\.
- •4\. Prior exposure to trastuzumab if the patient had developed severe
- •hypersensitivity reactions.
- •5\. Exclusion criterion 5 deleted by Protocol Amendment 2\.
- •6\. Prior treatment on a SU011248 clinical trial.
- •7\. Major surgery, radiation therapy, or systemic therapy within 3 weeks of first dose
Outcomes
Primary Outcomes
Not specified
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