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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096434 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane |
Study Start Date: | September 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months until disease progression and then every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 20-42 patients will be accrued for this study within 5-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
HER2-positive or -negative disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
No concurrent therapeutic anticoagulation
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Investigator: | Roscoe F. Morton, MD, FACP | John Stoddard Cancer Center at Iowa Methodist Medical Center |
Study ID Numbers: | CDR0000393224, NCCTG-N0336 |
Study First Received: | November 9, 2004 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00096434 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer male breast cancer |
Skin Diseases Breast Neoplasms, Male Breast Neoplasms Taxane |
Sorafenib Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |