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Home > "E" Clinical Trials Conditions > Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer  Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
For Condition: Neoplasm Metastasis,Breast Cancer
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: The purpose of this study is to test whether SU-011,248 has activity and is safe in patients with Metastatic Breast Cancer (MBC).
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: - Histologically or cytologically proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent - Received treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings - Relapse or progression of disease during treatment or within 12 months of the last dose of anthracycline or taxane - Resolution of acute toxicities of prior therapies - If receiving bisphosphonate therapy for metastatic bone disease, must have initiated therapy at least 3 months prior to study entry - Disease that can be measured using radiographic techniques - Females, 18 years of age or older - ECOG performance status 0 or 1 - Adequate organ function - No prior treatment with chemotherapy agents other than anthracyclines and taxanes in the advanced/metastatic disease setting - No prior treatment with tyrosine kinase inhibitors, vascular endothelial growth factor inhibitors, or other angiogenic inhibitors - No previous high-dose chemotherapy requiring hematopoietic stem cell rescue - No known brain metastases, spinal cord compression, or carcinomatous meningitis - No diagnosis of non-breast malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri - No serious acute or chronic illness or recent history of significant cardiac abnormality
Total Enrollment: 63
Location and Contact Information:
Pfizer Investigational Site *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting
Additional Information:
Study ID Numbers: A6181002;
Study Start Date: March 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078000
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4. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
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Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
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