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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
Other Neoplasm Metastasis Studies:
1. A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
2. Treatment of Patients with Metastatic Renal Cell Carcinoma with Neutralizing Antibody to Vascular Endothelial Growth Factor (VEGF)
3. Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer
4. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
5. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
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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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