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Sponsors and Collaborators: |
Lombardi Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217399 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: anastrozole Drug: sorafenib tosylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of BAY-43-9006 (Sorafenib) in Combination With Anastrozole in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of sorafenib.
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion, including ≥ 1 of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, as defined by 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following within the past 6 months:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
No concurrent agents that may interact with sorafenib, including any of the following:
United States, Connecticut | |
Yale Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06520-8028 | |
Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
United States, Maryland | |
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Recruiting |
Baltimore, Maryland, United States, 21237 | |
Contact: Clinical Trials Office - Harry & Jeanette Weinberg Cancer Inst 443-777-7364 | |
United States, Virginia | |
Medical Oncology and Hematology Associates of North Virginia - Fairfax | Recruiting |
Fairfax, Virginia, United States, 22031 | |
Contact: Mary J. Wilkinson, MD 703-720-5210 |
Study Chair: | Claudine Isaacs, MD | Lombardi Cancer Research Center |
Study ID Numbers: | CDR0000440067, GUMC-2004-251, NCI-6584 |
Study First Received: | September 20, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00217399 |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer |
Anastrozole Skin Diseases Breast Neoplasms |
Sorafenib Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |